ReagentsInfectious diseasesOther virology tests (infect. immunology/NAT)

Other virology - NA reagents

EMDN code W01050405

100 manufacturers, 711 models including 698 on the market, 21 countries

On the market in Models on the market only Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 100

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Vitrosens	Türkiye	ChainFor Adenovirus Detection qPCR Kit CFP3898/79 ChainFor Astrovirus Detection qPCR Kit CFP3998/79 ChainFor Human Metapneumovirus (hMPV) Detection qPCR Kit CFP7798/79 ChainFor Influenza A/B Detection qPCR Kit CFP6498/79 ChainFor Influenza ID-2 Genotyping Detection qPCR Kit CFP6798/79 48 others ChainFor Influenza ID-3 Genotyping Detection qPCR Kit CFP6698/79 ChainFor Norovirus GI + GII Detection qPCR Kit CFP5798/79 ChainFor Norovirus GI Detection qPCR Kit CFP4098/79 ChainFor Norovirus GII Detection RT-qPCR Kit CFP4198/79 ChainFor Parechovirus Detection qPCR Kit CFP7898/79 ChainFor Rhinovirus Detection qPCR Kit CFP7998/79 ChainFor Rotavirus Detection qPCR Kit CFP4298/79 ChainFor™3 refs ChainFor™ CFP192P10098/79 ChainFor™ CFP192P2598/79 ChainFor™ CFP192P5098/79 ChainFor™ CFP194P5098/79 ChainFor™ CFP195P10098/79 ChainFor™ HHV-6/HHV-7 Genotyping qPCR Kit2 refs ChainFor™ HHV-8 qPCR Kit3 refs ChainFor™ Influenza A ID-4 Genotyping Detection qPCR Kit CFP6598/79 LyoSens FLU A qPCR Kit LYO146WS9698/79 LyoSens FLU B qPCR Kit LYO147WS9698/79 LyoSens JCV qPCR Kit LYO100WS9698/79 LyoSens Adenovirus Detection qPCR Kit LYO1298/79 LyoSens ADV Quantitative qPCR Kit LYO130WS9698/79 LyoSens Astrovirus Detection qPCR Kit LYO1398/79 LyoSens BKV qPCR Kit LYO97WS9698/79 LyoSens CCHFV Detection qPCR Kit LYO7698/79 LyoSens Chikungunya Virus Detection qPCR Kit LYO6598/79 LyoSens Dengue Virus Detection qPCR Kit LYO6698/79 LyoSens FLU A + B qPCR Kit LYO37WS9698/79 LyoSens H1N1 Detection qPCR Kit LYO3398/79 LyoSens hMPV Detection qPCR Kit LYO4998/79 LyoSens Influenza A ID-4 Genotyping qPCR Kit LYO3898/79 LyoSens Influenza ID-2 Genotyping qPCR Kit LYO4098/79 LyoSens Influenza ID-3 Genotyping qPCR Kit LYO3998/79 LyoSens Norovirus GI + GII Detection qPCR Kit LYO3098/79 LyoSens Norovirus GI LYO1498/79 LyoSens Norovirus GII Detection qPCR Kit LYO1598/79 LyoSens Parechovirus Detection qPCR Kit LYO5098/79 LyoSens Parvovirus B19 Detection qPCR Kit LYO6498/79 LyoSens Rhinovirus Detection qPCR Kit LYO5198/79 LyoSens Rotavirus Detection qPCR Kit LYO1698/79 LyoSens RSV A + B qPCR Kit LYO148WS9698/79 LyoSens West Nile Virus Detection qPCR Kit LYO7298/79 LyoSens Zika Virus Detection qPCR Kit LYO7398/79 LyoSens™2 refs LyoSens™ LYO192WS9698/79 LyoSens™ LYO194WS2498/79 LyoSens™ LYO194WS4898/79 LyoSens™ LYO194WS9698/79 LyoSens™ LYO195WS4898/79	C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	4 Respiratory Pathogens Real Time RT-PCR Kit98/79 Adenovirus Real Time PCR Kit98/79 Avian Influenza Virus H5 Real Time RT-PCR Kit98/79 Avian Influenza Virus H5N1 Real Time RT-PCR Kit98/79 Avian Influenza Virus H7 Real Time RT-PCR Kit98/79 41 others Avian Influenza Virus H9 Real Time RT-PCR Kit98/79 Avian Influenza Virus Real Time RT-PCR Kit98/79 Chikungunya Virus Real Time RT-PCR Kit98/79 Crimean-Congo Hemorrhagic Fever Virus(CCHFV) Real Time RT-PCR Kit98/79 Dengue Fever Virus & Chikungunya Virus Real Time RT-PCR Kit98/79 Dengue Fever Virus Genotyping Ⅰ/Ⅱ/Ⅲ/Ⅳ Real Time RT-PCR Kit98/79 Dengue Virus (DENV)Lyo RT-PCR Kit98/79 Dengue Virus General-type Real Time RT-PCR Kit98/79 Dengue Virus I Real Time RT-PCR Kit98/79 Dengue Virus II Real Time RT-PCR Kit98/79 Dengue Virus III Real Time RT-PCR Kit98/79 Dengue Virus IV Real Time RT-PCR Kit98/79 Ebola Virus (EBOV) Real Time RT-PCR Kit98/79 Enterovirus 70（EV70）Real Time RT-PCR Kit98/79 Enterovirus 71(EV71) Real Time RT-PCR Kit98/79 Enterovirus Real Time RT-PCR Kit98/79 Hantavirus Pulmonary Syndrome Real Time RT-PCR Kit98/79 HantaVirus Renal Syndrome General-type I&II Real Time RT-PCR Kit98/79 Hantavirus Renal Syndrome Typing I&II Real Time RT-PCR Kit98/79 Human Astrovirus (HAstV) Real Time RT-PCR Kit98/79 Human Bocavirus（HBoV）Real Time PCR Kit98/79 Human Infections with Avian Influenza A Virus (H7N9) RNA Real Time RT-PCR Kit98/79 Human Metapneumovirus (hMPV) Real Time RT-PCR kit98/79 Human Parvovirus (B19) Real Time PCR Kit98/79 IFVA/H1N1/IFVB Test98/79 Influenza Virus H3N2 Real time RT-PCR Kit98/79 Influenza Virus H5N1 Real Time RT-PCR Kit98/79 Influenza virus H5N2 Real Time RT-PCR Kit98/79 JCV Real Time PCR Kit98/79 NoroVirus Genogroup I Real Time RT-PCR Kit98/79 Norovirus Genogroup II Real Time RT-PCR Kit98/79 NoroVirus Real Time RT-PCR Kit2 refs98/79 Polyomavirus BK (PBK) Real Time PCR Kit2 refs98/79 Respiratory AdenoVirus Real Time PCR Kit98/79 Respiratory Syncytial Virus (RSV) Typing A &B Real Time RT-PCR Kit2 refs98/79 Respiratory Syncytial Virus(RSV) Real Time RT-PCR Kit98/79 Rotavirus (Group B) Real Time RT-PCR Kit98/79 Rotavirus (Group C) Real Time RT-PCR Kit98/79 Rotavirus Real Time RT-PCR Kit98/79 West Nile Virus Real Time RT-PCR Kit98/79 Zika Virus (ZIKV) Real Time RT-PCR Kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Sansure FDA EU representative : Lotus NL B.V. (Netherlands) and 2 others	China	Adenovirus 40 and 41 Nucleic Acid Detection Kit (PCR-Fluorescence Probing)2 refs98/79 Adenovirus 41 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Adenovirus and Adenovirus 3/7 Subtypes Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Adenovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)3 refs98/79 Astrovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 43 others Avian Influenza Virus (H7N9) Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing)98/79 Avian influenza virus H3 RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Avian influenza virus H3N2 RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Avian influenza virus H5 RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Avian influenza virus H7 RNA Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Avian influenza virus H9 RNA Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 BK Virus DNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Chikungunya virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Coxsachievirus A10 Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing)98/79 Coxsachievirus A6 and A10 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Coxsachievirus A6 Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing)98/79 Dengue Fever Virus General-type Diagnostic Kit (PCR-Fluorescence Probing)98/79 Diagnostic Kit for Coxsackievirus A16 RNA (PCR-Fluorescence Probing)98/79 Diagnostic Kit for Enterovirus 71 RNA (PCR-Fluorescence Probing)98/79 Diagnostic Kit for Enterovirus RNA (PCR-Fluorescence Probing)98/79 Diagnostic Kit for Influenza A (H1N1) Virus（PCR-Fluorescence Probing）2 refs98/79 Echovirus E11 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Echovirus E30 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Enterococcus Faecalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Enterococcus Faecium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Enterococcus Faeciuma and Enterococcus Faecalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Escherichia coli O157 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Human Rotavirus A and B Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Human Rotavirus A/B/C Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Influenza A (H5N1) Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing）2 refs98/79 Influenza A and BV/BY RNA Diagnositc Kit（PCR-Fluorescence Probing）2 refs98/79 Influenza A Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Influenza A/B Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Influenza BV/BY RNA Diagnostic Kit（PCR-Fluorescence Probing）2 refs98/79 JC Virus DNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Parainfluenza Virus type 1, 2 and 3 Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)3 refs98/79 Respiratory Adenovirus DNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Respiratory Syncytial Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 S3401E98/79 Severe Fever With Thrombocytopenia Syndrome Bunyavirus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 West Nile Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Zika Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Dengue Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 (no longer marketed) Human Rotavirus A Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) Human Rotavirus B Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) Influenza B Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 (no longer marketed) Norovirus GI and GII Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) Severe Fever with Thrombocytopenia Syndrome Bunyavirus（SFTSV） Nucleic Acid Detection Kit(PCR-Fluorescence Probing)2 refs98/79 (no longer marketed)	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
TIB MOLBIOL Syntheselabor	Germany	LightMix®KIT Polyomavirus JC/BK CE98/79 ModularDx Kit Adenovirus98/79 ModularDx Kit Adenovirus F98/79 ModularDx Kit Astrovirus98/79 ModularDx Kit Bocavirus 530 LightMix® Modular Bocavirus 53098/79 23 others ModularDx Kit Bocavirus 580 LightMix® Modular Bocavirus 58098/79 ModularDx Kit Chikungunya Virus98/79 ModularDx Kit Dengue Virus98/79 ModularDx Kit Enterovirus 500 LightMix® Modular Enterovirus 50098/79 ModularDx Kit Enterovirus 640 LightMix® Modular Enterovirus 64098/79 ModularDx Kit Influenza A98/79 ModularDx Kit Influenza A H1 (H1N1 sw) LightMix® Modular Influenza A H1(H1N1 sw)98/79 ModularDx Kit Influenza B98/79 ModularDx Kit Metapneumovirus98/79 ModularDx Kit Norovirus GG1 Cyan LightMix® Modular Norovirus GG1 Cyan98/79 ModularDx Kit Norovirus GG1 FAM LightMix® Modular Norovirus GG1 FAM98/79 ModularDx Kit Norovirus GG2 FAM LightMix® Modular Norovirus GG2 FAM98/79 ModularDx Kit Parainfluenza 1 LightMix® Modular Parainfluenza 198/79 ModularDx Kit Parainfluenza 2 LightMix® Modular Parainfluenza 298/79 ModularDx Kit Parainfluenza 3 LightMix® Modular Parainfluenza 398/79 ModularDx Kit Parainfluenza 4 LightMix® Modular Parainfluenza 498/79 ModularDx Kit Parechovirus HPeV 530 LightMix® Modular Parechovirus HPeV 53098/79 ModularDx Kit Parechovirus HPeV 640 LightMix® Modular Parechovirus HPeV 64098/79 ModularDx Kit Rotavirus A98/79 ModularDx Kit RSV-A/B98/79 ModularDx Kit Zika Virus 640 LightMix® Modular Zika Virus 64098/79 ModularDx Kit Zika Virus CE98/79 UC-TIB-AdV98/79	– 98/79	Website EUDAMED record Report an error
Idilbiotech	Türkiye	RevoDx Adenovirus (F40/41) qPCR Kit2 refs98/79 RevoDx Adenovirus qPCR Kit2 refs98/79 RevoDx Avian Influenza (H5N1) qPCR Kit2 refs98/79 RevoDx BK Virus qPCR Kit2 refs98/79 RevoDx BK Virus Quantitative qPCR Kit2 refs98/79 22 others RevoDx Bocavirus 1/2/3/4 qPCR Kit2 refs98/79 RevoDx Crimean-Congo Hemorrhagic Fever Virus qPCR Kit2 refs98/79 RevoDx Dengue Virus Screening qPCR Kit2 refs98/79 RevoDx Dengue Virus Typing qPCR Kit2 refs98/79 RevoDx Enterovirus/Rhinovirus qPCR Kit2 refs98/79 RevoDx Human herpes virus 6 (HHV-6) qPCR Kit2 refs98/79 RevoDx Human herpes virus 7 (HHV-7) qPCR Kit2 refs98/79 RevoDx Human Metapneumovirus qPCR Kit2 refs98/79 RevoDx Human parechovirus qPCR Kit2 refs98/79 RevoDx Influenza A H1N1 (pdm09) qPCR Kit2 refs98/79 RevoDx Influenza A-H3 qPCR Kit2 refs98/79 RevoDx JC Virus qPCR Kit2 refs98/79 RevoDx JC Virus Quantitative qPCR Kit2 refs98/79 RevoDx Monkeypox qPCR Kit2 refs98/79 RevoDx Norovirus genogroup I&II qPCR Kit2 refs98/79 RevoDx Parainfluenza virus 1 qPCR Kit2 refs98/79 RevoDx Parainfluenza virus 2 qPCR Kit2 refs98/79 RevoDx Parainfluenza virus 3 qPCR Kit2 refs98/79 RevoDx Parainfluenza virus 4 qPCR Kit2 refs98/79 RevoDx Rotavirus A qPCR Kit2 refs98/79 RevoDx RSV qPCR Kit2 refs98/79 RevoDx Zika Virus qPCR Kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	ADENOVİRÜS MİKTARLANDIRMA KİTİ BATI NİL TESPİT KİTİ BKV TESPİT KİTİ BOCAVIRUS DETECTION KIT VSNR016 DENGUE VİRÜSÜ GENOTİPLEME KİTİ 22 others DENGUE VİRÜSÜ TESPİT KİTİ ENTEROVIRUS DETECTION KIT VSNMP054 H1N1 TESPİT KİTİ H1N1 DETECTION KIT HHV-8 DETECTION KIT HHV6-HHV7 DETECTION KIT HUMAN METAPNEUMOVIRUS DETECTION KIT VSNR001 INF A/H1 TESPİT KİTİ INF A/H1 DETECTION KIT INF A/H1-2009 TESPİT KİTİ INF A/H1-2009 DETECTION KIT INF A/H3 TESPİT KİTİ INF A/H3 DETECTION KIT İNFLUENZA A-H5N1 TESPİT KİTİ INFLUENZA A- H5N1 DETECTION KIT İNFLUENZA -A,B TESPİT KİTİ İNFLUENZA -B TESPİT KİTİ İNFLUENZA A-B-C TARAMA KİTİ İNFLUENZA H5N2 TESPİT KİTİ INFLUENZA H5N2 DETECTION KIT İNFLUENZA TİPLEME KİTİ İNFLUENZA-A TESPİT KİTİ PARAİNFLUENZA (1, 2, 3, 4) TESPİT KİTİ PARAINFLUENZA (1, 2, 3, 4) DETECTION KIT SOLUNUM SİNSİTİYAL VİRÜSÜ (RSV) -A,B TESPİT KİTİ SOLUNUM SİNSİTİYAL VİRÜSÜ (RSV) – B TESPİT KİTİ SOLUNUM SİNSİTİYAL VİRÜSÜ (RSV) – TEST KİTİ ZIKA VİRÜSÜ TESPİT KİTİ ÇİKUNGUNYA VİRÜSÜ TESPİT KİTİ	B, C IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
altona Diagnostics FDA	Germany	AltoStar® Adenovirus PCR Kit 1.5 AltoStar® BKV PCR Kit 1.5 AltoStar® HHV-6 PCR Kit 1.5 AltoStar® Influenza Screen & Type RT-PCR Kit 1.598/79 AltoStar® JCV PCR Kit 1.5 21 others AltoStar® Norovirus RT-PCR Kit 1.5 AltoStar® Parvovirus B19 PCR Kit 1.5 RealStar® Adenovirus PCR Kit 1.098/79 RealStar® BKV PCR Kit 1.098/79 RealStar® CCHFV RT-PCR Kit 1.098/79 RealStar® Chikungunya RT-PCR Kit 2.098/79 RealStar® Dengue RT-PCR Kit 2.098/79 RealStar® Dengue RT-PCR Kit 3.098/79 RealStar® Enterovirus RT-PCR Kit 1.098/79 RealStar® Filovirus Screen RT-PCR Kit 1.098/79 RealStar® HHV-6 PCR Kit 1.098/79 RealStar® hMPV RT-PCR Kit 2.098/79 RealStar® Influenza Screen & Type RT-PCR Kit 4.098/79 RealStar® JCV PCR Kit 1.098/79 RealStar® Norovirus RT-PCR Kit 3.098/79 RealStar® Parvovirus B19 PCR Kit 1.098/79 RealStar® PIV RT-PCR Kit 2.098/79 RealStar® Rotavirus RT-PCR Kit 1.098/79 RealStar® RSV RT-PCR Kit 3.098/79 RealStar® WNV RT-PCR Kit 2.098/79 RealStar® Zika Virus RT-PCR Kit 1.098/79	B, C IVDR, 98/79	info@altona-diagnostics.com EUDAMED record Report an error
Suzhou TianLong Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Andes virus (ANDV) Nucleic Acid Detection Kit (Fluorescence PCR Method)2 refs98/79 Astrovirus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Avian Influenza Virus H7 Universal/HPAI-H7/N9 Subtype RNA Detection Kit (Fluorescence PCR Method)98/79 Dengue Virus Genotyping (I/II/III/IV) Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Ebola Virus (Zaire) Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 15 others Enterovirus Universal RNA Detection Kit (Fluorescence PCR Method)98/79 Hantaan Virus/Seoul Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Human Adenovirus (Ad) Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Human Influenza Virus A/B & Respiratory Syncytial Virus Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Human Influenza Virus B (Yamagata&Victoria) and A (H1&H3) Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Human Influenza Virus B Genotyping (Yamagata&Victoria) Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Human Metapneumovirus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Influenza A/B Virus RNA Detection Kit (Fluorescence PCR Method)98/79 Influenza A/Influenza B/Respiratory Syncytial Virus (RSV) Nucleic Acid Detection Kit (Fluorescence PCR Method-0.1mL Pre-filled)98/79 Norovirus (NoV) Genotype GI/GII Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Respiratory Syncytial Virus Genotype A/B Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Respiratory Syncytial Virus Universal RNA Detection Kit (Fluorescence PCR Method)98/79 Rotavirus Genotype A/B/C Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Rotavirus Universal RNA Detection Kit (Fluorescence PCR Method)98/79 ZiKa Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Clonit	Italy	DENGUE Serotyping RT-0398/79 quanty Adenovirus RT-3498/79 quanty Adenovirusqs QS-3498/79 quanty BKV RT-3298/79 quanty BKVqs QS-3298/79 14 others quanty CHIKUNGUNYA RT-0598/79 quanty Enterovirus RT-3398/79 quanty Enterovirusqs QS-3398/79 quanty HHV-7 RT-2998/79 quanty HHV-7qs QS-2998/79 quanty HHV6 RT-3098/79 quanty HHV6qs QS-3098/79 quanty HHV8 RT-3198/79 quanty HHV8qs QS-3198/79 quanty JCV RT-2498/79 quanty JCVqs QS-2498/79 quanty Parvo B19 RT-1798/79 quanty Parvo B19qs QS-1798/79 quanty WNV RT-0498/79	– 98/79	Website info@clonit.it EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) and 1 other	China	Duplex Real-Time PCR Diagnostic Kit for Rapid Detection of Ebola-Zaire2 refs98/79 Multiple Real-Time PCR Detection Kit for Norovirus GI/GII2 refs98/79 Quadruplex Real-time PCR Detection Kit for Dengue Fever Type I / II / III / IV98/79 Real-time PCR Detection Kit for Bocavirus98/79 Real-time PCR Detection Kit for Chikungunya98/79 12 others Real-time PCR Detection Kit for Dengue Type I98/79 Real-time PCR Detection Kit for Enteral Adenovirus98/79 Real-Time PCR Detection Kit for Enterovirus98/79 Real-time PCR Detection Kit for Monkeypox Virus2 refs98/79 Real-time PCR Detection Kit for Norovirus GI98/79 Real-time PCR Detection Kit for Norovirus GII98/79 Real-time PCR Detection Kit for Novel Bunyavirus98/79 Real-time PCR Detection Kit for Respiratory Syncytial Virus98/79 Real-Time PCR Detection Kit for Universal Dengue98/79 Real-time PCR Detection Kit for Zika98/79 Real-Time PCR Diagnostic Kit for Human Enterovirus 71 (EV71) (TaqMan probe method)98/79 Real-Time PCR Diagnostic Kit for Rapid Detection of Respiratory Adenovirus98/79	– 98/79	EUDAMED record Report an error
Poly Diagnostics	Luxembourg	Poly Diagnostics Adenovirus, RNase P Real-Time PCR kit3 refs Poly Diagnostics Astrovirus, RNase P Real-Time PCR kit3 refs Poly Diagnostics Bocavirus, RNase P Real-Time PCR kit3 refs Poly Diagnostics HMPV A/B, RNase P Real-Time PCR kit3 refs Poly Diagnostics HRSV a/b, RNase P Real-Time PCR kit3 refs 12 others Poly Diagnostics Influenza A, Influenza B, Influenza C, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza A, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza B, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza typing II Real-Time PCR kit3 refs Poly Diagnostics Influenza typing Real-Time PCR kit3 refs Poly Diagnostics Norovirus GI, Norovirus GII+GIV, RNase P Real-Time PCR kit3 refs Poly Diagnostics Parainfluenza viruses 1, 2, 3, 4 Real-Time PCR kit3 refs Poly Diagnostics Parainfluenza viruses 1, 2, 3/4, RNase P Real-Time PCR kit3 refs Poly Diagnostics Parechovirus, HMPV A/B, Bocavirus, RNase P Real-Time PCR kit3 refs Poly Diagnostics Parechovirus, RNase P Real-Time PCR kit3 refs Poly Diagnostics Rhinovirus/Enterovirus, RNase P Real-Time PCR kit3 refs Poly Diagnostics Rotavirus A, RNase P Real-Time PCR kit3 refs	B IVDR	Website info@polydiagnostics.com EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany)	China	Adenovirus (Respiratory Type) Nucleic Acid Detection Kit (Fluorescence)98/79 Bocavirus Nucleic Acid Detection Kit (Fluorescence)98/79 Chikungunya Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Dengue Virus Genotyping Nucleic Acid Detection Kit (Fluorescence)98/79 Dengue Virus Genotyping Nucleic Acid Detection Kit Nc04798/79 11 others Dengue Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Enterovirus (Non-Poliovirus) Nucleic Acid Detection Kit98/79 Enterovirus (Non-Poliovirus) Nucleic Acid Detection Kit (Fluorescence)98/79 Influenza A/B Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Measles Virus Nucleic Acid Detection Kit Nc00698/79 Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Parainfluenza Virus (I-IV) Nucleic Acid Detection Kit (Fluorescence)98/79 Respiratory Syncytial Virus (A/B) Nucleic Acid Detection Kit (Fluorescence)98/79 Rhinovirus Nucleic Acid Detection Kit (Fluorescence)98/79 West Nile Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Zika Virus Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	EUDAMED record Report an error
Vela Operations Singapore Pte FDA EU representative : Vela Diagnostics Germany GmbH (Germany)	Singapore	Sentosa SA BKV Controls (8x3) 30063398/79 Sentosa SA BKV PCR Test (4x24) 30008898/79 Sentosa SA BKV PCR Test (4X48) 30063698/79 Sentosa SA BKV Quantitation Controls (4x2) 30009298/79 Sentosa SA BKV Quantitation Standards (2x13) 30009198/79 11 others Sentosa SA CHIKV RT-PCR Test (4x8) 30004898/79 Sentosa SA Dengue I-IV RT-PCR Test (4x8) 30005098/79 Sentosa SA HHV6 Controls Set (8x3) 30068898/79 Sentosa SA HHV6 Quantitation Controls (4x2) 30017898/79 Sentosa SA HHV6 Quantitative PCR Test 300157, 300184, 300673, 30018098/79 Sentosa SA Influenza A/B & 2009 H1N1 RT-PCR Test 11126798/79 Sentosa SA Influenza A/B & RSV RT-PCR Test (4x24) 30014598/79 Sentosa SA Norovirus RT-PCR Test v2.0 (4x24) 30020298/79 Sentosa SA Rotavirus RT-PCR Test (4x24) 30019298/79 Sentosa SA RSV RT-PCR Test 11132698/79 Sentosa SA ZIKV RT-PCR Test 30061498/79	– 98/79	Website infoAPAC@veladx.com EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Avian Influenza Virus (H5/H7/H9) Real Time PCR Kit YJC10301NW-25T98/79 Avian Influenza Virus (H5/H7/H9) Real Time PCR Kit YJC10301NW-50T98/79 Avian Influenza Virus Subtype H5N2 Real Time PCR Kit JC10215NW-25T98/79 Avian Influenza Virus Subtype H5N2 Real Time PCR Kit JC10215NW-50T98/79 Enteric Adenovirus Real Time PCR Kit YJC50106NW-25T98/79 10 others Enteric Adenovirus Real Time PCR Kit YJC50106NW-50T98/79 Enterovirus Real Time PCR Kit JC20101NW-25T98/79 Enterovirus Real Time PCR Kit JC20101NW-50T98/79 Influenza A and B Viruses Real Time PCR Kit2 refs98/79 Influenza Virus Subtype N6 Real Time PCR Kit JC10134NW-25T98/79 Influenza Virus Subtype N6 Real Time PCR Kit JC10134NW-50T98/79 Rift Valley Fever Virus Real Time PCR Kit YJC70111NW-25T2 refs98/79 Rotavirus A B C Real Time PCR Kit YJC50301NW-25T98/79 Rotavirus A B C Real Time PCR Kit YJC50301NW-50T98/79 West Nile Virus Real Time PCR Kit YJC70109NW-25T98/79	– 98/79	EUDAMED record Report an error
Vitassay	Spain	Vitassay qPCR Astrovirus98/79 Vitassay qPCR BK98/79 Vitassay qPCR Chikungunya98/79 Vitassay qPCR Dengue98/79 Vitassay qPCR Dengue 1+2+3+498/79 10 others Vitassay qPCR Flu A + Flu B98/79 Vitassay qPCR Human Herpes Virus98/79 Vitassay qPCR MonkeyPox98/79 Vitassay qPCR Noro (I&II)98/79 Vitassay qPCR Parainfluenza 1-3+2-498/79 Vitassay qPCR Rotavirus98/79 Vitassay qPCR RSV A + RSV B98/79 Vitassay qPCR Type I/Flu98/79 Vitassay qPCR West Nile98/79 Vitassay qPCR Zika98/79	– 98/79	Website info@vitassay.com EUDAMED record Report an error
Geneproof	Czechia	GeneProof Adenovirus MC PCR Kit2 refs98/79 GeneProof Adenovirus PCR Kit2 refs98/79 GeneProof BK Virus (BKV) MC PCR Kit2 refs98/79 GeneProof BK Virus (BKV) PCR Kit2 refs GeneProof Enterovirus PCR Kit2 refs98/79 9 others GeneProof Human Herpesvirus 6/7 (HHV-6/7) MC PCR Kit2 refs98/79 GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit3 refs GeneProof Human Herpesvirus 8 (HHV-8) MC PCR Kit2 refs98/79 GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit3 refs GeneProof JC Virus (JCV) MC PCR Kit2 refs98/79 GeneProof JC Virus (JCV) PCR Kit2 refs GeneProof Parvovirus B19 PCR Kit2 refs98/79 TaqPath™ Menu4 refs98/79 TaqPath™ Menu GeneProof Parvovirus B19 PCR Kit98/79	C IVDR, 98/79	Website support@geneproof.com EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi	Türkiye	Adenovirus Quantification Kit (24)3 refs98/79 Adenovirus Quantification Kit (48)3 refs98/79 Adenovirus Quantification Kit (96)3 refs HHV6 Quantification Kit (24)3 refs98/79 HHV6 Quantification Kit (48)3 refs98/79 7 others HHV6 Quantification Kit (96)3 refs98/79 Parvovirus B19 Quantification Kit (24)3 refs98/79 Parvovirus B19 Quantification Kit (48)3 refs98/79 Parvovirus B19 Quantification Kit (96)3 refs98/79 West Nile Virus Detection and Monitoring Kit (24)3 refs98/79 West Nile Virus Detection and Monitoring Kit (48)3 refs98/79 West Nile Virus Detection and Monitoring Kit (96)3 refs98/79	C IVDR, 98/79	Website EUDAMED record Report an error
Certest	Spain	VIASURE Adenovirus plus Real Time PCR Detection Kit3 refs VIASURE Adenovirus q Real Time PCR Detection Kit3 refs VIASURE Astrovirus Real Time PCR Detection Kit3 refs VIASURE BK virus q Real Time PCR Detection Kit3 refs VIASURE Chikungunya Virus Real Time PCR Detection Kit3 refs 7 others VIASURE Flu A + B Real Time PCR Detection Kit3 refs VIASURE Flu Typing II Real Time PCR Detection Kit3 refs VIASURE Human Herpes Virus 6, 7 & 8 Real Time PCR Detection Kit3 refs VIASURE Norovirus GI + GII Real Time PCR Detection Kit3 refs VIASURE Parainfluenza Real Time PCR Detection Kit3 refs VIASURE Rotavirus Real Time PCR Detection Kit3 refs VIASURE RSV A + B Real Time PCR Detection Kit3 refs	B, C IVDR	Website quality@certest.es EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Adenovirus IgM Detection Kit(CLIA) 50 Tests/kit98/79 Coxsackie virus group A type 16 (CA16) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Enterovirus type 71 (EV71) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Enterovirus Universal Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Influenza A (H1N1) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 5 others Influenza A+B virus Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Mycoplasma Pheumonia IgM (MP IgM) Detection Kit(CLIA) 50 Tests/kit98/79 Norovirus type GI/GII Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Respiratory Syncytial Virus IgM (RSV-IgM) Detection Kit(CLIA) 50 Tests/kit98/79 Rotavirus (group A/B/C) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79	– 98/79	Website sales@szzijian.com EUDAMED record Report an error
R-Biopharm FDA	Germany	RIDA®GENE Adenovirus98/79 RIDA®GENE Enterovirus98/79 RIDA®GENE Flu98/79 RIDA®GENE Norovirus98/79 RIDA®GENE Norovirus I & II98/79 5 others RIDA®GENE Parainfluenza98/79 RIDA®UNITY Flu RIDA®UNITY Norovirus I & II RIDA®UNITY Parainfluenza RIDA®GENE Norovirus GI_GII98/79 (no longer marketed)	B IVDR, 98/79	Website EUDAMED record Report an error
ElitechGroup FDA	Italy	Adenovirus - ELITe Positive Control3 refs BKV - ELITe Positive Control3 refs ENTEROVIRUS - ELITe Positive Control3 refs GI Norovirus PLUS - ELITe Positive Control2 refs HHV6 - ELITe Positive Control HHV6 ELITe MGB® Kit3 refs 4 others HHV8 - ELITe Positive Control HHV8 ELITe MGB® Kit3 refs JCV - ELITe Positive Control3 refs Parvovirus B19 - ELITe Positive Control Parvovirus B19 ELITe MGB® Kit3 refs WNV ELITe MGB® Kit98/79	B, C IVDR, 98/79	Website EUDAMED record Report an error
Bioer FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Adenovirus and Adenovirus type 3, 4 and 7 Nucleic Acid Detection Kit (Fluorescent PCR) BSJ06M198/79 Adenovirus and Adenovirus type 3, 4 and 7 Nucleic Acid Detection Kit (Fluorescent PCR) BSJ06S198/79 Dengue Virus Nucleic Acid Detection Kit (Fluorescent PCR) BSJ43L198/79 Dengue Virus Nucleic Acid Detection Kit (Fluorescent PCR) BSJ43M198/79 Human Parainfluenza Virus Type 1, Type 2, Type 3 Nucleic Acid Detection Kit (Fluorescence PCR) BSJ11L198/79 3 others Human Parainfluenza Virus Type 1, Type 2, Type 3 Nucleic Acid Detection Kit (Fluorescence PCR) BSJ11M198/79 Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR) BSJ04S1, BSJ04M1, BSJ04L13 refs Respiratory Syncytial Virus Type A / Type B Nucleic Acid Detection Kit (Fluorescent RT- PCR) BSJ05S1, BSJ05M1, BSJ05L13 refs	B IVDR, 98/79	Website ra_oversea@bioer.com.cn EUDAMED record Report an error
Daan Gene EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	24 tests/kit7 refs98/79 48 tests/kit98/79 Large package, 10 tests/kit4 refs98/79 Large package, 24 tests/kit2 refs98/79 Large package, 48 tests/kit7 refs98/79 3 others Single tube, 10 tests/kit6 refs98/79 Single tube, 20 tests/kit2 refs98/79 Single tube, 48 tests/kit98/79	– 98/79	EUDAMED record Report an error
Ecolidx	Czechia	eSens Dengue virus type QL PCR kit98/79 eSens Enterovirus QL PCR kit98/79 eSens HHV6 QT PCR kit98/79 eSens HHV7 QT PCR kit98/79 eSens HHV8 QT PCR kit98/79 3 others eSens Parvovirus B19 QT PCR kit98/79 eSens WNV QL PCR kit98/79 eSens Zika virus QL PCR kit98/79	– 98/79	Website EUDAMED record Report an error
Gold Standard Diagnostics FDA	Germany	Adenovirus IgA98/79 Adenovirus IgG98/79 Adenovirus IgM98/79 NovaLisa® Adenovirus IgM2 refs98/79 NovaLisa® Adenovirus IgA2 refs98/79 3 others NovaLisa® Adenovirus IgG2 refs98/79 RSV A, RSV B PRSV616198/79 RSV A, RSV B PRSV616498/79	– 98/79	info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Medunion S.L. (Spain) and 1 other	China	Dengue Virus Genotyping Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)98/79 Dengue virus nucleic acid test kit (Fluorescent Probe-based Real-time PCR Assay)3 refs98/79 EV71, CA16 and Other Enteroviral Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)98/79 EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)5 refs98/79 Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)2 refs98/79 3 others Kit de Prueba de Ácido Nucleico del Virus del Dengue (Ensayo de PCR en tiempo real basado en sonda fluorescente)98/79 Monkeypox Virus Nucleic Acid Detection Kit (Fluorescent Probe-based Real-time PCR Assay)98/79 Zika virus, Dengue virus and Chikungunya virus Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)98/79	– 98/79	EUDAMED record Report an error
Advanced Molecular Diagnostics EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	ZENA MAX BK Virus Real Time PCR Detection Kit98/79 ZENA MAX Dengue Virus Real Time PCR Detection Kit98/79 ZENA MAX Human Adenovirus (HAdV) Real Time PCR Detection Kit98/79 ZENA MAX Human Herpesvirus 6 (HHV-6) Real Time PCR Detection Kit98/79 ZENA MAX Human Herpesvirus 8 (HHV-8) Real Time PCR Detection Kit98/79 2 others ZENA MAX Influenza A(H1N1)pdm09 Real Time PCR Detection Kit98/79 ZENA MAX Parvovirus B19 Real Time PCR Detection Kit98/79	– 98/79	Website info@am-diagnostics.co.uk EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium)	India	Adeno-Q Real-Time PCR Kit G2M70782198/79 BK-Q Real Time PCR Kit for BK virus G2M70542198/79 Chikungunya-Q Real- Time PCR Test Kit G2M70532198/79 DENGUE-Q Real Time PCR Kit G2M70502198/79 Rota-Q Real Time PCR Kit for Rotavirus G2M80162198/79 2 others W. Nile-Q Real Time PCR Kit for West Nile Virus G2M80232198/79 ZikaQ Real Time PCR Kit for Zika Virus G2M26262198/79	– 98/79	Website EUDAMED record Report an error
gerbion	Germany	alphaCube Entero 2.098/79 alphaCube TBE98/79 SMD lead EnteroRhino98/79 virellaEntero 2.0 TM real time RT-PCR Kit98/79 virellaNoro real time RT-PCR Kit TM98/79 2 others virellaTBE real time RT-PCR Kit TM98/79 virellaWNV real time RT-PCR98/79	– 98/79	info@gerbion.com EUDAMED record Report an error
Ingenetix	Austria	ViroReal® Kit Adenovirus98/79 ViroReal® Kit Enterovirus98/79 ViroReal® Kit Influenza A/B98/79 ViroReal® Kit Metapneumovirus98/79 ViroReal® Kit Parainfluenzavirus98/79 2 others ViroReal® Kit Rhinovirus (A, B, C)98/79 ViroReal® Kit RSV (A & B)98/79	– 98/79	Website office@ingenetix.com EUDAMED record Report an error
Ortho-Clinical Diagnostics Dba Quidel EU representative : MDSS GmbH (Germany)	United States	D3 Enterovirus Reagent Duo Pack98/79 Lyra Adenovirus Assay98/79 Lyra Influenza A+B Assay98/79 Lyra Parainfluenza Virus Assay98/79 Quidel Molecular Adenovirus Control Set98/79 2 others Quidel Molecular Influenza A+B Control Set98/79 Quidel Molecular Parainfluenza Virus Control Set98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
Ab Analitica	Italy	REALQUALITY InFLU-Typing2 refs98/79 REALQUALITY RQ-ADENO4 refs98/79 REALQUALITY RQ-BKV4 refs98/79 REALQUALITY RQ-BKV STANDARD2 refs98/79 REALQUALITY RQ-ENTERO8 refs98/79 1 other REALQUALITY RQ-PARVO B194 refs98/79	– 98/79	customersupport@abanalitica.it EUDAMED record Report an error
Aitbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	Singapore	30010798/79 30010898/79 30015598/79 30015698/79 30018598/79 1 other 30018698/79	– 98/79	Website EUDAMED record Report an error
bioMérieux FDA	France	ADENOVIRUS R-GENE® 69-010B BK Virus R-GENE® 69-013B ENTEROVIRUS R-GENE® 69-005B HHV6 R-GENE® Parechovirus R-GENE® 1 other Parvovirus B19 R-GENE®	C IVDR	EUDAMED record Report an error
Eurobio Scientific	France	EurobioPlex BK Virus3 refs98/79 EurobioPlex Dengue 12343 refs98/79 EurobioPlex HHV6-HHV83 refs98/79 EurobioPlex JC Virus3 refs98/79 EurobioPlex Parvovirus B193 refs98/79 1 other EurobioPlex Zika Virus3 refs98/79	– 98/79	reglementaire@eurobio-scientific.com EUDAMED record Report an error
KH Medical EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	RADI Chikungunya Detection Kit98/79 RADI Dengue Virus Detection Kit98/79 RADI Ebola Virus Detection Kit98/79 RADI FAST Influenza A/B Detection Kit98/79 RADI FAST RSV A/B Detection Kit98/79 1 other RADI West nile virus Detection Kit98/79	– 98/79	Website info@khmedical.co.kr EUDAMED record Report an error
Hecin EU representative : Share info GmbH (Germany)	China	AccuProbe Influenza A Virus PCR Kit3 refs AccuProbe Influenza A/B Virus PCR Kit3 refs AccuProbe Influenza B Virus PCR Kit3 refs AccuProbe RSV PCR Kit3 refs HCPlex RSV PCR Kit3 refs	B IVDR	EUDAMED record Report an error
Shanghai BioGerm Medical Technology EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	6-in-1 Respiratory Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 50 tests/kit98/79 Influenza A/B & RSV Nucleic Acid Detection Kit (Fluorescent RT-MIRA) 24 tests/kit Sampling tube with 0.75mL Lysis Buffer98/79 Influenza A/B & RSV Nucleic Acid Detection Kit (Fluorescent RT-MIRA) 24 tests/kit Sampling tube with 2.5mL Lysis Buffer98/79 Norovirus Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 50 tests/kit98/79 Respiratory Syncytial Virus/HumanParainfluenza Virus /Human Rhinovirus Nucleic Acid Detection Kit (Fluorescent RT-MIRA) 24 tests/kit98/79	– 98/79	EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	EasyNAT Rapid Flu Assay EasyNAT Rapid RSV Assay MultNAT EV Assay MultNAT Monkeypox Virus Assay98/79 MultNAT Norovirus Assay98/79	B, C IVDR, 98/79	Website service@bioustar.com EUDAMED record Report an error
Vidia	Czechia	ELISA-VIDITEST anti-HHV-6 IgG3 refs98/79 ELISA-VIDITEST anti-HHV-6 IgG (CSF)3 refs98/79 ELISA-VIDITEST anti-HHV-6 IgM3 refs98/79 MONO-VIDITEST anti-HHV-6 IgG2 refs98/79 MONO-VIDITEST anti-HHV-6 IgM2 refs98/79	– 98/79	Website EUDAMED record Report an error
ZeptoMetrix FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	NATtrol™ Influenza A/B Positive Control NATtrol™ Influenza/RSV Negative Control NATtrol™ Norovirus GI/GII Positive Control NATtrol™ Norovirus Negative Control NATtrol™ RSV Positive Control	B IVDR	Website EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic	Türkiye	Anatolia Geneworks Bosphore BKV Quantification Kit v13 refs98/79 Anatolia Geneworks Bosphore CCHFV Quantification Kit v13 refs98/79 Anatolia Geneworks Bosphore HHV-6/7/8 Quantification Kit v13 refs98/79 Anatolia Geneworks Bosphore Parvovirus B19 Quantification Kit v13 refs98/79	– 98/79	Website info@anatoliagenetik.com EUDAMED record Report an error
Cesna	Türkiye	INFLUENZA A-B, H1N1 DETECTION KIT INFLUENZA-A,B DETECTION KIT CSNP016 SOLUNUM SİNSİTİYAL VİRÜSÜ (RSV) – B TESPİT KİTİ SOLUNUM SİNSİTİYAL VİRÜSÜ (RSV) – TEŞHİS KİTİ	B IVDR	Website info@cesna.com.tr EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany)	China	Cowingene Dengue Virus Detection Kit98/79 Cowingene Dengue Virus I/II/III/IV Detection Kit98/79 Cowingene Monkeypox Virus Detection Kit98/79 Cowingene Monkeypox Virus Typing Detection Kit98/79	– 98/79	Website EUDAMED record Report an error
Genekam	Germany	D0046-cDNA positive-Control for Influenza Virus H598/79 FR006-FluHunter: Avian Influenza Virus H5N1 (Realtime PCR-Kit)98/79 FR074-Dengue Fever Virus -(Realtime PCR-Kit)98/79 FR325-Zika Virus-Single Check (Realtime PCR-Kit)98/79	– 98/79	Website office@genekam.de EUDAMED record Report an error
Hangzhou Danwei Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	101A0211EY，101A0211ED98/79 AMPV01，AMPV01D98/79 CDGV01A-AHG4E98/79 CMTBMDR01A-AHG4E98/79	– 98/79	ra.danwei@danwei-bio.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	ADV01-AHG48E; ADV01-AHG96E; ADV01D-AHG48E; ADV01D-AHG96E98/79 ADV01D-AHG48E; ADV01D-AHG96E98/79 AMPV01-AHG48E; AMPV01-AHG96E98/79 AMPV01D-AHG48E; AMPV01D-AHG96E98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Iontek	Türkiye	Fluorion BKV QNP 1.0 Real-Time PCR Kit98/79 Fluorion Influenza A/B QLP 1.0 Real-Time PCR Kit98/79 Fluorion Rhinovirus QLP 1.0 Real-Time PCR Kit98/79 Fluorion RSV QLP 1.0 Real-Time PCR Kit98/79	– 98/79	Website EUDAMED record Report an error
Molbio Diagnostics EU representative : QbD RepS BV (Belgium)	India	Truenat Influenza A/B 60120000598/79 Truenat Influenza A/B 60120002098/79 Truenat Influenza A/B 60120002598/79 Truenat Influenza A/B 60120005098/79	– 98/79	Website customersupport@molbiodiagnostics.com EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	United States	ADVIA Centaur Zika Ab DX_LS_LEGACY_0063041424702198/79 ADVIA Centaur Zika IgM DX_LS_LEGACY_0063041424700798/79 Atellica IM Zika Ab DX_LS_LEGACY_0063041428685398/79 Atellica IM Zika IgM DX_LS_LEGACY_0063041428683998/79	– 98/79	Website contact@siemens-healthineers.com EUDAMED record Report an error
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Detection Kit for Adenovirus Nucleic Acids (PCR-Fluorescence Probing) ADV001-4898/79 Detection Kit for Monkeypox Virus(PCR Fluorescence Probing)98/79 Detection Kit for Respiratory Syncytial Virus RNA (PCR Fluorescence Probing)98/79 Nucleic Acid Detection Kit for Human Metapneumovirus (PCR-Fluorescence Probing)98/79	– 98/79	sales@singuway.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Methicillin-resistant Staphylococcus Aureus qPCR Kit98/79 Monkeypox Virus Detection qPCR Kit98/79 Norovirus Rapid Test Cassette (Feces) INO-60298/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Kogene EU representative : Obelis s.a. (Belgium)	South Korea	PowerChek™ Influenza B (Victoria & Yamagata) Real-time PCR Kit Ver.1.198/79 PowerChek™ Norovirus GI / GII Multiplex Real-time PCR Kit98/79 PowerChek™ Parainfluenza Virus 1/2/3 Real-time PCR Kit98/79	– 98/79	Website info@kogene.co.kr EUDAMED record Report an error
Nanjing Synthgene Medical Technology FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Adenovirus Rapid Test Kit (Colloidal gold method) CR03598/79 Chikungunya Fever IgG/IgM Antibody Test Kit (Colloidal Gold Method)98/79 Rotavirus Antigen Rapid Test Kit (Colloidal gold method) CR03298/79	– 98/79	Website sales@syngenebio.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	ADV01-AOG48E;,ADV01-AOG96E,ADV01D-AOG48E,ADV01D-AOG96E98/79 AMPV01-AOG48E; AMPV01-AOG96E98/79 CDGV01A-AOG4E98/79	– 98/79	EUDAMED record Report an error
Abiores Technology (Beijing) EU representative : Medunion S.L. (Spain)	China	Monkeypox Virus Fluorescence PCR Kit Cassette98/79 Monkeypox Virus Fluorescence PCR Kit（Direct qPCR） Cassette98/79	– 98/79	EUDAMED record Report an error
Aesku FDA	Germany	AESKULISA® Parvovirus B19 IgG98/79 AESKULISA® Parvovirus B19 IgM98/79	– 98/79	Website EUDAMED record Report an error
Anchor Diagnostics	Germany	Anchor Influenza A/B PCR Kit98/79 Anchor Norovirus PCR Kit98/79	– 98/79	info@anchor-diagnostics.com EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Medunion S.L. (Spain)	China	Adenovirus Antigen Test Kit (Colloidal Gold) Cassette98/79 Human Metapneumovirus (hMPV) Antigen Test Kit Cassette2 refs98/79	– 98/79	sales@dbluemedical.com EUDAMED record Report an error
Bgi	Denmark	BGI 50 tests/kit98/79 BGI 50 tests/package98/79	– 98/79	Website EUDAMED record Report an error
Bioeksen	Türkiye	Bio-Speedy® CCHFV RT-qPCR Detection Kit2 refs98/79 Bio-Speedy® West Nile Virus Real-Time PCR Detection Kit2 refs98/79	– 98/79	Website info@bioeksen.com.tr EUDAMED record Report an error
Coyotebio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	FlashDetect6 refs98/79 FlashDetect™ LyocartE Enterovirus 71 Assay98/79	– 98/79	sales@coyotebio.com EUDAMED record Report an error
Daltonbio EU representative : Medunion S.L. (Spain)	China	Influenza A Virus Nucleic Acid Detection Kit (Isothermal Amplification Method)98/79 Influenza B Virus Nucleic Acid Detection Kit (Isothermal Amplification Method)98/79	– 98/79	Website EUDAMED record Report an error
Diapro	Italy	ENTEROVIRUS ONE-STEP ENTERONE.CE98/79 JCV DNA Quantitation (QT) JCVDNAQT.CE98/79	– 98/79	Website info@diapro.it EUDAMED record Report an error
GenDx FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	GENEYE® Influenza Virus （FluA/B）ERA Assay98/79 GENEYE® Respiratory Syncytial Virus（RSV）ERA Assay98/79	– 98/79	EUDAMED record Report an error
Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH	Germany	PoET B19V98/79 PoET WNV98/79	– 98/79	Website info@gfeblut.de EUDAMED record Report an error
Guangzhou Deaou Gene Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	4 tests/kit98/79 8 tests/kit98/79	– 98/79	EUDAMED record Report an error
Hangzhou Zhunxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	HA-01198/79 HA-01798/79	– 98/79	EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Canada	Ocular viral Detection Kit (Fluorescence PCR) AOPV0198/79 Rapid Human Adenovirus DNA Test RADV0198/79	– 98/79	sales@orientgene.com EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Diagnostic Kit for Influenza A virus RNA (Fluorescence RT-PCR)98/79 Epidemic Hemorrhagic Fever (EHF) IgM Antibody Enzyme Immunoassay Test Kit98/79	– 98/79	Website EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium)	United States	Panther Fusion Flu A/B/RSV Assay2 refs Panther Fusion Paraflu Assay2 refs	B IVDR	EUDAMED record Report an error
Immundiagnostik FDA	Germany	MutaPLEX® Enterovirus, PCR2 refs98/79 MutaPLEX® Norovirus, PCR2 refs98/79	– 98/79	Website info@immundiagnostik.com EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Enterovirus Universal, EV71 and CoxA16 Nucleic Acid Detection Kit (Fluorescence PCR)98/79 Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-RT176A3 refs	B IVDR, 98/79	marketing@hongweitest.com EUDAMED record Report an error
Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇	Türkiye	Dansite Reagent R1 Dansite Reaktif R198/79 Nitrit Reagent R1 Nitrit Reaktif R198/79	– 98/79	info@kinetikkimya.com EUDAMED record Report an error
Norgen Biotek EU representative : Emergo Europe B.V. (Netherlands)	Canada	JCV TaqMan PCR Kit Dx NoV TaqMan RT-PCR Kit Dx	B IVDR	Website regulatory@norgenbiotek.com EUDAMED record Report an error
Progenie molecular S.L.U	Spain	RealCycler ADNV-ABI3298/79 RealCycler ADNV-UX98/79	– 98/79	EUDAMED record Report an error
Tellgencorp EU representative : MedNet EC-REP GmbH (Germany)	China	Dengue Virus Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79 EVU/CoxA16 and EV71 Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79	– 98/79	Website sales@tellgen.com EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain)	China	20 tests/kit98/79 40 tests/kit98/79	– 98/79	EUDAMED record Report an error
PathoFinder	Netherlands	RealAccurate® Quadruplex Parainfluenza PCR kit PF0972-R98/79 RealAccurate® Quadruplex Influenza PCR Kit PF0970-R (no longer marketed)	B IVDR, 98/79	Website info@pathofinder.com EUDAMED record Report an error
Abacus Diagnostica	Finland	GenomEra Norovirus Assay kit CDX-1002 refs98/79	– 98/79	info@abacusdiagnostica.com EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany)	United States	Alinity m3 refs	C IVDR	EUDAMED record Report an error
Biobase Diagnostic Technology (Shandong) EU representative : Luxus Lebenswelt GmbH (Germany)	China	Monkeypox Virus Real Time PCR Kit 50 rxns/kit98/79	– 98/79	EUDAMED record Report an error
BioChain (Beijing) Science & Technology EU representative : Medunion S.L. (Spain)	China	24 Tests/Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Cepheid FDA	Sweden	Xpert®98/79	– 98/79	Website EUDAMED record Report an error
Clongene FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Monkeypox Virus PCR Test Kit IMPX00Na98/79	– 98/79	Website marketing@clongene.com EUDAMED record Report an error
Credo Diagnostics Biomedical Pte Taiwan Branch EU representative : MedNet EC-REP GmbH (Germany)	Taiwan	VitaPCR Flu A&B Assay98/79	– 98/79	service@credodxbiomed.com EUDAMED record Report an error
Diagenode FDA	Belgium	Panther Fusion BKV Quant Assay - BKV Reagent Cartridge2 refs	C IVDR	info@diagenode.com EUDAMED record Report an error
Elisabeth	Czechia	EliGene® Influenza A/B/pandemic LC98/79	– 98/79	Website info@elisabeth.cz EUDAMED record Report an error
Genobio Pharmaceutical FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Monkeypox Virus Molecular Detection Kit (Real-time PCR)2 refs98/79	– 98/79	Website marketing@era-bio.com EUDAMED record Report an error
Hain Lifescience	Germany	FluoroType® BKV HT VER 1.0	C IVDR	EUDAMED record Report an error
Hangzhou Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Chikungunya IgG/IgM Rapid Test HCHI012T98/79	– 98/79	info@jgbiotech.com EUDAMED record Report an error
Igenesis Shanghai EU representative : CMC Medical Devices & Drugs SL (Spain)	China	12 reactions/kit98/79	– 98/79	support@igenesisbio.com EUDAMED record Report an error
Isiabio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Influenza A/B (Flu A/B) virus antigen Rapid Test Kit (QDs Immunofluorescence Method) Flu A/B-QD98/79	– 98/79	Website EUDAMED record Report an error
Jiangsu Q-Array EU representative : Caretechion GmbH (Germany)	China	Dengue virus Nucleic Acid Multiplex Detection Kit (Fluorescence PCR)98/79	– 98/79	EUDAMED record Report an error
Lysunbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	LYSUN FLU-S21（25PCS）98/79	– 98/79	EUDAMED record Report an error
MedicalSystem Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands)	China	Influenza A+B Rapid Test Cassette 1T98/79	– 98/79	EUDAMED record Report an error
Viuick EU representative : SUNGO Europe B.V. (Netherlands)	China	VIUICK98/79	– 98/79	EUDAMED record Report an error
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	U-CardDx™ 2003 refs98/79	– 98/79	Website sales@wondfo.com.cn EUDAMED record Report an error
Princeton BioMeditech FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) No model still on the market	United States	BioSign Flu A&B98/79 (no longer marketed) Immunocard STAT Flu A&B98/79 (no longer marketed) Immunocard STAT Flu A&B Nasopharyngeal Wash/Aspirate accessory kit98/79 (no longer marketed) Status Flu A+B98/79 (no longer marketed)	– 98/79	Website info@pbmc.com EUDAMED record Report an error
Uniogen No model still on the market	Finland	GenomEra Norovirus Assay kit CDX-1002 refs98/79 (no longer marketed)	– 98/79	info@uniogen.com EUDAMED record Report an error

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