Infectious diseasesOther virology tests (infect. immunology/NAT)Other virology - NA reagents

Virology - NA reagents - other

EMDN code W0105040599

55 manufacturers, 279 models including 277 on the market, 13 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 55

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
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	3 Insect-Vector Pathogens Real Time RT-PCR Kit98/79 5 Insect-borne Pathogen Detection kit2 refs98/79 7 Rodent-carrying Pathogen Detection kit98/79 8 Viral Diarrhea Pathogens Multiplex Real Time PCR Kit98/79 Anaplasma phagocytophilum Real Time PCR Kit98/79 29 others BP/CP/MP Test98/79 Coxsackie Virus A16 Real Time RT-PCR Kit98/79 Coxsackie Virus A24 Real Time RT-PCR Kit98/79 Coxsackie Virus Real Time RT-PCR Kit98/79 CYP2C19 Gene Polymorphism Real Time PCR Kit98/79 Ehrlichia Real Time PCR Kit98/79 Encephalomyocarditis virus (EMCV) Real Time RT-PCR Kit98/79 Foot-and-Mouth Disease Virus(FMDV) Real Time RT-PCR Kit98/79 Human Echovirus 30 Real Time RT-PCR Kit98/79 Human Rhinovirus (HRV) Real Time RT-PCR Kit98/79 IFVA & IFVB & H5/H7N9 Test98/79 IFVA H3 H1N1 & IFVB Test98/79 Lassa Virus (LV) Real Time RT-PCR Kit98/79 Lumpy Skin Disease Virus, Sheeppox Virus and Goatpox Virus Test98/79 Marburg Virus (MBV) Real Time RT-PCR Kit98/79 Monkeypox Virus Lyo-PCR Kit2 refs98/79 Monkeypox Virus Real Time PCR Kit98/79 Monkeypox Virus Real Time PCR Test Kit98/79 Nipah Virus (NiV) Real Time RT-PCR Kit98/79 Parechovirus Real Time RT-PCR Kit98/79 Rabies Virus Real Time RT-PCR Kit98/79 Rift Valley Fever Virus (RVFV) Real Time RT-PCR Kit98/79 Thrombocytopenia Syndrome Bunyavirus (SFTSV) Real Time RT-PCR Kit98/79 Toscana Virus (TOSV) Real Time RT-PCR Kit98/79 Transfusion-transmitted Virus (TTV) Real Time PCR Kit98/79 Vibrio Cholera CTX Gene/O1/O139 Real Time PCR Kit98/79 Yellow Fever Virus (YFV) Lyo RT-PCR Kit2 refs98/79 Yellow Fever Virus (YFV) Real Time RT-PCR Kit98/79 ZIKA and Yellow Fever Test98/79	– 98/79	Website EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany)	China	Adenovirus (Respiratory Type) Nucleic Acid Detection Kit Nc02998/79 Bocavirus Nucleic Acid Detection Kit Nc03498/79 Chikungunya Virus Nucleic Acid Detection Kit Nc02498/79 Dengue Virus Nucleic Acid Detection Kit Nc00898/79 Human Metapneumovirus Nucleic Acid Detection Kit (Fluorescence)98/79 22 others Human Metapneumovirus Nucleic Acid Detection Kit Nc03098/79 Influenza A/B Virus Nucleic Acid Detection Kit Nc01798/79 Japanese Encephalitis Virus Nucleic Acid Detection Kit98/79 Japanese Encephalitis Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Measles Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Measles Virus Nucleic Acid Detection Kit Nc00698/79 Monkeypox Virus Nucleic Acid Detection Kit Nc00998/79 Nc00298/79 Nipah Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Nipah Virus Nucleic Acid Detection Kit (Nasopharyngeal Swab)98/79 Norovirus Nucleic Acid Detection Kit (Fluorescence)98/79 Norovirus Nucleic Acid Detection Kit Nc01898/79 Oropouche Virus Nucleic Acid Detection Kit98/79 Oropouche Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Parainfluenza Virus (I-IV) Nucleic Acid Detection Kit98/79 Plasmodium Nucleic Acid Detection Kit Nc01698/79 Poliovirus Nucleic Acid Detection Kit (Fluorescence)98/79 Respiratory Syncytial Virus (A/B) Nucleic Acid Detection Kit Nc02898/79 Rhinovirus Nucleic Acid Detection Kit (Nasopharyngeal Swab) Nc03398/79 West Nile Virus Nucleic Acid Detection Kit Nc02298/79 Yellow Fever Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Zika Virus Nucleic Acid Detection Kit Nc02398/79	– 98/79	EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	CoxA16 & EV71 Real Time PCR Kit JC20203NW-25T98/79 CoxA16 & EV71 Real Time PCR Kit JC20203NW-50T98/79 CoxA16/EV71/EV-U Real Time PCR Kit JC20303NW-25T98/79 CoxA16/EV71/EV-U Real Time PCR Kit JC20303NW-50T98/79 Hantavirus Real Time PCR Kit YJC60124NW-25T98/79 21 others Hantavirus Real Time PCR Kit YJC60124NW-50T98/79 Japanese Encephalitis Virus Real Time PCR Kit YJC70108NW-25T98/79 Japanese Encephalitis Virus Real Time PCR Kit YJC70108NW-50T98/79 Monkeypox Virus (MPXV) Fast Real Time PCR Kit2 refs98/79 Monkeypox Virus and Orthopoxvirus Real Time PCR Kit YJC70205NW-25T98/79 Monkeypox Virus and Orthopoxvirus Real Time PCR Kit YJC70205NW-50T98/79 Monkeypox Virus Genotyping Real Time PCR Kit YJC70204NW-50T98/79 Monkeypox Virus Real Time PCR Kit YJC70204NW-25T98/79 Monkeypox Virus Varicella-zoster Virus/Variola Virus Real Time PCR Kit YJC70303NW-25T98/79 Monkeypox Virus Varicella-zoster Virus/Variola Virus Real Time PCR Kit YJC70303NW-50T98/79 Nipah Virus Real Time PCR Kit JC40106NW-25T98/79 Nipah Virus Real Time PCR Kit JC40106NW-50T98/79 Rabies Virus Real Time PCR Kit YJC70105NW-25T98/79 Rabies Virus Real Time PCR Kit YJC70105NW-50T98/79 Rift Valley Fever Virus Real Time PCR Kit YJC70111NW-50T98/79 Tick-borne Encephalitis Virus Real Time PCR Kit98/79 Tick-borne Encephalitis Virus Real Time PCR Kit YJC70113NW-50T98/79 Toscana Virus Real Time PCR Kit YJC30108NW-25T98/79 Toscana Virus Real Time PCR Kit YJC30108NW-50T98/79 Yellow Fever Virus Real Time PCR Kit JC40107NW-25T98/79 Yellow Fever Virus Real Time PCR Kit JC40107NW-50T98/79	– 98/79	EUDAMED record Report an error
Vitrosens	Türkiye	ChainFor Sapovirus Detection qPCR Kit CFP4398/79 ChainFor™8 refs ChainFor™ CFP127P2598/79 ChainFor™ CFP127P5098/79 ChainFor™ CFP75P5098/79 14 others ChainFor™ CFP93P10098/79 ChainFor™ CFP93P2598/79 ChainFor™ CFP93P5098/79 LyoSens Monkeypox Detection qPCR Kit LYO7198/79 LyoSens Sapovirus Detection qPCR Kit LYO1798/79 LyoSens TTV Detection qPCR Kit LYO7598/79 LyoSens™3 refs LyoSens™ LYO127WS4898/79 LyoSens™ LYO75WS2498/79 LyoSens™ LYO75WS4898/79 LyoSens™ LYO75WS9698/79 LyoSens™ LYO93WS2498/79 LyoSens™ LYO93WS4898/79 LyoSens™ LYO93WS9698/79	C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Sansure FDA EU representative : Lotus NL B.V. (Netherlands) and 2 others	China	Babesia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Ebola Virus and Lassa Fever Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Human Herpers Virus 6 DNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Human Metapneumovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)3 refs98/79 Monkeypox virus Nucleic Acid Diagnostic Kit (LAMP) S3361E-2498/79 12 others Monkeypox virus Nucleic Acid Diagnostic Kit (LAMP) S3361E-4898/79 Monkeypox virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)3 refs98/79 Mycoplasma genitalium DNA Diagnostic Kit（PCR-Fluorescence Probing）98/79 Nipah Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Nocardia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Rabies Virus RNA Nucleic Acid Diagnostic Kit ( PCR-Fluorescence Probing )98/79 Salmonella/Yersinia Enterocolitica/Campylobacter Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Six Diarrhea Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)2 refs98/79 Talaromyces marneffei DNA Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Yellow fever virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Monkeypox virus DNA Fluorescence Diagnostic Kit (LAMP) S3362E-2498/79 (no longer marketed) Sapovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed)	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
KH Medical EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	RADI CDZ Virus Detection Kit98/79 RADI COVID-19 Detection Kit98/79 RADI FAST COVID-19 Detection Kit98/79 RADI FAST Mpox Detection Kit RV01598/79 RADI Flu-SC2 Detection Kit98/79 6 others RADI Monkeypox Detection Kit98/79 RADI MTB Detection Kit98/79 RADI Rift Valley Fever Virus Detection Kit98/79 RADI STI-10 Detection Kit98/79 RADI Vibrio cholera Detection KIT98/79 RADI Yellow Fever Virus Detection Kit98/79	– 98/79	Website info@khmedical.co.kr EUDAMED record Report an error
R-Biopharm FDA	Germany	RIDA®GENE Flu & RSV98/79 RIDA®GENE Pediatric Viral Panel98/79 RIDA®GENE RSV & hMPV98/79 RIDA®GENE Sapovirus98/79 RIDA®GENE Viral Stool Panel I98/79 6 others RIDA®GENE Viral Stool Panel II98/79 RIDA®GENE Viral Stool Panel III98/79 RIDA®UNITY Flu & RSV RIDA®UNITY RSV & hMPV RIDA®UNITY Viral Stool Panel II RIDA®UNITY Viral Stool Panel IV	B IVDR, 98/79	Website EUDAMED record Report an error
Daan Gene EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	1 tests/kit2 refs98/79 25 tests/kit2 refs98/79 Large package, 24 tests/kit5 refs98/79 Large package, 48 tests/kit8 refs98/79 Large package, 480 tests/kit3 refs98/79 5 others Large package, 96 tests/kit6 refs98/79 Large package, 960 tests/kit3 refs98/79 Single tube, 24 tests/kit2 refs98/79 Single tube, 48 tests/kit2 refs98/79 Single tube, 96 tests/kit2 refs98/79	– 98/79	EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Influenza A and B Virus RT-qPCR Kit98/79 Influenza A/B and Respiratory Syncytial Virus RT-qPCR Kit98/79 Monkeypox Virus Detection qPCR Kit98/79 Monkeypox Virus qPCR Kit98/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test INRA-63598/79 4 others Respiratory Syncytial Virus RT-qPCR Kit98/79 SARS-CoV-2 and Influenza A/B Virus RT-qPCR Kit98/79 SARS-CoV-2 Nucleic Acid Detection Kit (CRISPR Lateral Flow Assay)98/79 SARS-CoV-2, Influenza Virus and Respiratory Syncytial Virus RT-qPCR Kit98/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Suzhou TianLong Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Coxsackie A6/A10 Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Dengue Virus/ZiKa Virus/Chikungunya Virus Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Diarrhea Virus (5 Viruses) Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Enterovirus 71/Coxsackie A16/ Enterovirus Universal RNA Detection Kit (Fluorescence PCR Method)98/79 Influenza A/Influenza B/Human Adenovirus/2019-nCoV Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 4 others Influenza A/Influenza B/SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Sapovirus/Adenovirus/Astrovirus Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Yellow Fever Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Ningbo HEALTH Gene Technologies EU representative : Lotus NL B.V. (Netherlands)	China	13Respiratory Pathogen Multiplex Detection Kit (PCR Capillary Electrophoresis Fragment Analysis)98/79 Influenza A/B Virus Nucleic Acid Rapid Test Kit (colloidal gold)98/79 Influenza A/B Virus, Respiratory Syncytial Virus, Adenovirus and Mycoplasma Pneumonia Nucleic Acid Detection Kit98/79 Meningitis/Encephalitis Pathogen Multiplex Detection Kit(PCR-Capillary Electrophoresis Fragment Analysis)98/79 Monkeypox virus Detection Diagnostic Kit (qPCR Method)98/79 3 others Monkeypox virus Nucleic Acid Rapid Detection Kit(colloidal gold)98/79 Monkeypox virus Nucleic Acid Rapid Detection Kit(Fluorescence)98/79 SRAS-CoV-2 virus, Influenza A/B virus, Respiratory syncytial virus and Adenovirus nucleic acid Detection kit (RT-qPCR)98/79	– 98/79	EUDAMED record Report an error
Idilbiotech	Türkiye	RevoDx BK/JC Virus qPCR Kit98/79 RevoDx BK/JC Virus Screening qPCR Kit2 refs98/79 RevoDx CMV / EBV / HHV-6 qPCR Kit2 refs98/79 RevoDx HHV-6/7 Screening qPCR Kit2 refs98/79 RevoDx Langya Virus qPCR Kit2 refs98/79 2 others RevoDx Oropouche Virus qPCR Kit2 refs98/79 RevoDx Rabies virus qPCR Kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Monkeypox Virus and Typing Nucleic Acid Detection Kit (Fluorescence PCR)98/79 Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification) 16 tests/kit98/79 Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification) 20 tests/kit98/79 Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification) 48 tests/kit98/79 Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification) 50 tests/kit98/79 1 other Monkeypox Virus Typing Nucleic Acid Detection Kit (Fluorescence PCR)98/79	– 98/79	marketing@hongweitest.com EUDAMED record Report an error
Clonit	Italy	COVID-19 HT Screen 501 RT-25HT50198/79 COVID-19 HT Screen RT-25HT98/79 FluA/FluB/SARS-CoV-2 RT-2698/79 quanty USUTU RT-2098/79 quanty ZIKA RT-4098/79	– 98/79	Website info@clonit.it EUDAMED record Report an error
Certest	Spain	VIASURE ADV, CMV, EBV & PB19 Real Time PCR Detection Kit3 refs VIASURE Monkeypox virus Real Time PCR Detection Kit3 refs VIASURE Mumps, Enterovirus & Parechovirus Real Time PCR Detection Kit3 refs VIASURE Sapovirus Real Time PCR Detection Kit3 refs	B, C IVDR	Website quality@certest.es EUDAMED record Report an error
Coyotebio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	FlashDetect4 refs FlashDetect™ Lyocart SARS-CoV-2&Flu A&Flu B&RSV 2.0 Assay98/79 FlashDetect™ LyocartE FluA&FluB&RSV Assay98/79 FlashDetect™ LyocartE SARS-CoV-2&FluA&FluB&RSV Assay3 refs98/79	C IVDR, 98/79	sales@coyotebio.com EUDAMED record Report an error
Molbio Diagnostics EU representative : QbD RepS BV (Belgium)	India	Truenat H1N1 60107000598/79 Truenat H1N1 60107002098/79 Truenat H1N1 60107002598/79 Truenat H1N1 60107005098/79	– 98/79	Website customersupport@molbiodiagnostics.com EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	2019-nCoV Nucleic acid Detection Kit (Real Time PCR) 48 Tests/kit98/79 Monkeypox Virus Detection Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Mutation of SARS-CoV-2 nucleic acid Detection Kit (Real Time PCR) 48 Tests/kit98/79 Novel Coronavirus(SARS-CoV-2) Nucleic Acid Detection Kit (Isothermal Amplification) 48 Tests/kit98/79	– 98/79	Website sales@szzijian.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	GASTRO PATOJENLERİ TARAMA KITI GASTROENTERITIS PANEL MAXI KIT GASTROENTERITIS PANEL V2 SCREENING KIT SARI HUMMA TESPİT KİTİ	C IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Ab Analitica	Italy	REALQUALITY ABFlu-CoV-23 refs98/79 REALQUALITY ResP-REM2 refs98/79 REALQUALITY RQ-JCV4 refs98/79	– 98/79	customersupport@abanalitica.it EUDAMED record Report an error
altona Diagnostics FDA	Germany	RealStar® Lassa Virus RT-PCR Kit 2.098/79 RealStar® Rift Valley Fever Virus RT-PCR Kit 1.098/79 RealStar® Yellow Fever Virus RT-PCR Kit 1.098/79	– 98/79	info@altona-diagnostics.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	Real-time PCR Detection Kit for Coxsackievirus A6 and Coxsackievirus A1098/79 Real-time PCR Detection Kit for Rift Valley Fever98/79 Real-time PCR Detection Kit for Yellow Fever98/79	– 98/79	EUDAMED record Report an error
Bioneer FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	AccuPower® RV Kit (ExiStation™ FA 96) AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit IRON-qPCR™ RV Kit	B IVDR	Website sales@bioneer.com EUDAMED record Report an error
Genekam	Germany	FR060-Fluhunter: Influenza A Virus (Ready to use Realtime PCR-Kit)98/79 FR077-FluHunter-Human swine flu H1N1 (Ready to use Realtime PCR-Kit)98/79 FR166-Yellow Fever Virus -(Realtime PCR-Kit)98/79	– 98/79	Website office@genekam.de EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium)	India	J.encephalitis -Q Real Time PCR Kit for Japanese encephalitis G2M80202198/79 MERS-Q Real Time PCR Kit for Middle East Respiratory Syndrome G2M80212198/79 Nipah-Q Real-Time PCR Kit G2M70592198/79	– 98/79	Website EUDAMED record Report an error
Genolution FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	DGD9613 refs NGD9613 refs NX-Jr Stool NA Kit A JGD0613 refs	A IVDR	Website EUDAMED record Report an error
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	U-CardDx™ 2003 refs98/79 U-Card™ 2009 refs98/79 U-Card™ 200 2019-nCoV/Flu/RSV Test3 refs98/79	– 98/79	Website sales@wondfo.com.cn EUDAMED record Report an error
Bioeksen	Türkiye	Bio-Speedy® Monkeypox Virus qPCR Kit98/79 Bio-Speedy® MPXV qPCR Kit98/79	– 98/79	Website info@bioeksen.com.tr EUDAMED record Report an error
Bioer FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Monkeypox Virus Nucleic Acid Multiple Detection Kit (Fluorescent PCR) BSJ34M198/79 Monkeypox Virus Nucleic Acid Multiple Detection Kit (Fluorescent PCR) BSJ34S198/79	– 98/79	Website ra_oversea@bioer.com.cn EUDAMED record Report an error
Hangzhou Danwei Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	AFCRC01-AHG4E98/79 CRTIZK01-AHG4E98/79	– 98/79	ra.danwei@danwei-bio.com EUDAMED record Report an error
Immundiagnostik FDA	Germany	MutaPLEX BV-1 quant. (LAC/AV/GV)98/79 MutaPLEX STI-2 (TV/MH/UPU)98/79	– 98/79	Website info@immundiagnostik.com EUDAMED record Report an error
Qiagen FDA	Germany	artus BK Virus QS-RGQ Kit98/79 artus BK Virus RG PCR Kit98/79	– 98/79	Website info@qiagen.com EUDAMED record Report an error
Rocgene FDA EU representative : Medunion S.L. (Spain)	China	10 tests/kit98/79 50 tests/kit98/79	– 98/79	sale@rocgene.com EUDAMED record Report an error
Vacure EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Monkeypox Virus Nucleic Acid Kit (Fluorescent PCR)98/79 Multiple (6 Items) Respiratory Virus Nucleic Acid Kit (Fluorescent PCR)98/79	– 98/79	EUDAMED record Report an error
Vitassay	Spain	Vitassay qPCR Japanese Encephalitis98/79 Vitassay qPCR Sapovirus98/79	– 98/79	Website info@vitassay.com EUDAMED record Report an error
-Diagnostics EU representative : mdi Europa GmbH (Germany)	United States	ZDC-K-00198/79	– 98/79	Website EUDAMED record Report an error
Advanced Molecular Diagnostics EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	ZENA MAX Monkeypox (MPXV) Real Time PCR Detection Kit98/79	– 98/79	Website info@am-diagnostics.co.uk EUDAMED record Report an error
bioMérieux FDA	France	TTV R-GENE®	C IVDR	EUDAMED record Report an error
Clongene FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	SARS-CoV-2 Nucleic Acid RT-PCR Test Kit ICOV52Nb, ICOV52Na98/79	– 98/79	Website marketing@clongene.com EUDAMED record Report an error
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy)	United States	Simplexa™ Flu A/B & RSV Direct Gen II98/79	– 98/79	Website ivdr_dsm@diasorin.com EUDAMED record Report an error
Dynamiker EU representative : Lotus NL B.V. (Netherlands)	China	25 tests/kit98/79	– 98/79	Website marketing@dynamiker.com EUDAMED record Report an error
Ecolidx	Czechia	eSens Poliovirus QL PCR kit98/79	– 98/79	Website EUDAMED record Report an error
Geneodx EU representative : Lotus NL B.V. (Netherlands)	China	Monkeypox Virus Nuclear Acid Detection Kit (Real Time PCR)98/79	– 98/79	RA@geneodx.com EUDAMED record Report an error
Genmark	Türkiye	geneMAP Monkeypox PCR Detection Kit, 50T98/79	– 98/79	Website info@genmark.com.tr EUDAMED record Report an error
Hangzhou DIAN Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	GENEDIAN SARS-CoV-2 and Influenza A/B Nucleic Acid Detection Kit98/79	– 98/79	EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	CRTIZK01-AHG4E98/79	– 98/79	EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Canada	Ocular Bacteria and Fungi Detection Kit (Fluorescence PCR) AOBF0198/79	– 98/79	sales@orientgene.com EUDAMED record Report an error
Ingenetix	Austria	BactoReal® Kit Mycoplasma pneumoniae98/79	– 98/79	Website office@ingenetix.com EUDAMED record Report an error
MedicalSystem Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands)	China	Monkeypox Virus Real Time PCR Kit 96T98/79	– 98/79	EUDAMED record Report an error
NanoEntek FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	En-swer™ COVID-19 RT-PCR Kit98/79	– 98/79	Website eudamed@nanoentek.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Monkeypox Virus Detection Kit (Fluorescence PCR)98/79	– 98/79	EUDAMED record Report an error
Shanghai BioGerm Medical Technology EU representative : Medunion S.L. (Spain)	China	Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 25 tests/kit ;2 refs	C IVDR	EUDAMED record Report an error
TIB MOLBIOL Syntheselabor	Germany	ModularDx Kit Picornavirus HRV+EV98/79	– 98/79	Website EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	EasyNAT Monkeypox Virus Assay98/79	– 98/79	Website service@bioustar.com EUDAMED record Report an error
Vazyme EU representative : Obelis s.a. (Belgium)	China	Novel Coronavirus (SARS-CoV-2) and Influenza A/B Virus RT-qPCR Detection Kit98/79	– 98/79	EUDAMED record Report an error

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