Infectious diseasesMultiple parameters - (infect. immunology/NAT)Multiple panels for infections - various

Respiratory tract infections - multiplex NA reagents

EMDN code W0105070503

76 manufacturers, 363 models including 352 on the market, 18 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 76

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
AusDiagnostics EU representative : Advena Limited (Malta) and 1 other	Australia	Respiratory Pathogens 12-well98/79 Respiratory Pathogens 12-well 80618P98/79 RIDA®Plex Atypical Pneumonia 8 well Step 198/79 RIDA®Plex Atypical Pneumonia 8 well Step 298/79 RIDA®Plex Pneumonia 16 well Step 198/79 35 others RIDA®Plex Pneumonia 16 well Step 298/79 RIDA®Plex Respiratory Pathogens 12 well Step 198/79 RIDA®Plex Respiratory Pathogens 12 well Step 298/79 RIDA®Plex Respiratory Pathogens 16 well Step 198/79 RIDA®Plex Respiratory Pathogens 16 well Step 298/79 RIDA®Plex Respiratory Pathogens 24 well Step 198/79 RIDA®Plex Respiratory Pathogens 24 well Step 298/79 RIDA®Plex Respiratory Pathogens B 16 well Step 198/79 RIDA®Plex Respiratory Pathogens B 16 well Step 298/79 RIDA®Plex Respiratory Pathogens C 16 well Step 198/79 RIDA®Plex Respiratory Pathogens C 16 well Step 298/79 RIDA®Plex Respiratory Viruses 16 well Step 198/79 RIDA®Plex Respiratory Viruses 16 well Step 298/79 RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well Step 198/79 RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well Step 298/79 RIDA®Plex Upper Respiratory Pathogens 16 well Step 198/79 RIDA®Plex Upper Respiratory Pathogens 16 well Step 298/79 Step 1 tubes for Atypical Pneumonia (8-well)98/79 Step 1 tubes for Pneumonia (16-well)98/79 Step 1 tubes for Respiratory Pathogens 16-well98/79 Step 1 tubes for Respiratory Pathogens 24-well98/79 Step 1 tubes for Respiratory Pathogens B 16-well98/79 Step 1 tubes for Respiratory Pathogens C 16-well98/79 Step 1 tubes for Respiratory Viruses (16-well)98/79 Step 1 tubes for SARS-CoV-2, Influenza and RSV 8-well98/79 Step 1 tubes for Upper Respiratory Pathogens 16-well98/79 Step 2 Plates for Atypical Pneumonia 8-well98/79 Step 2 Plates for Pneumonia (16-well)98/79 Step 2 Plates for Respiratory Pathogens 16-well98/79 Step 2 Plates for Respiratory Pathogens 24-well98/79 Step 2 Plates for Respiratory Pathogens B 16-well98/79 Step 2 Plates for Respiratory Pathogens C 16-well98/79 Step 2 Plates for Respiratory Viruses (16-well)98/79 Step 2 Plates for SARS-CoV-2, Influenza and RSV 8-well98/79 Step 2 Plates for Upper Respiratory Pathogens 16-well98/79	– 98/79	Website regulatory@r-biopharm.com.au EUDAMED record Report an error
Vitrosens	Türkiye	ChainFor Respiratory ID-4 Genotyping qPCR Kit CFP1398/79 ChainFor™5 refs ChainFor™ CFP102P2598/79 ChainFor™ CFP103P10098/79 ChainFor™ CFP103P2598/79 30 others ChainFor™ CFP116P2598/79 ChainFor™ CFP116P5098/79 ChainFor™ CFP117P10098/79 ChainFor™ CFP117P2598/79 ChainFor™ CFP129P10098/79 ChainFor™ CFP151P10098/79 ChainFor™ CFP151P2598/79 ChainFor™ CFP151P5098/79 ChainFor™ CFP152P5098/79 ChainFor™ CFP182P5098/79 ChainFor™ Respiratory ID-28 Genotyping qPCR Kit2 refs ChainFor™ Respiratory v1.0 Genotyping qPCR Kit3 refs ChainFor™ Respiratory v2.0 Genotyping qPCR Kit3 refs ChainFor™ Respiratory v3.0 Genotyping qPCR Kit3 refs ChainFor™ Respiratory v5.0 Genotyping qPCR Kit3 refs ChainFor™ Respiratory ID-7 Genotyping qPCR Kit3 refs LyoSens™ LYO101WS2498/79 LyoSens™ LYO101WS4898/79 LyoSens™ LYO101WS9698/79 LyoSens™ LYO103WS9698/79 LyoSens™ LYO116WS2498/79 LyoSens™ LYO116WS9698/79 LyoSens™ LYO129WS2498/79 LyoSens™ LYO151WS2498/79 LyoSens™ LYO151WS4898/79 LyoSens™ LYO182WS2498/79 LyoSens™ LYO182WS4898/79 LyoSens™ LYO182WS9698/79 LyoSens™ Respiratory v4.0 Genotyping qPCR Kit RapidFor™ IL-6 (FIA)2 refs	B, C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Idilbiotech	Türkiye	RevoDx Bacterial Respiratory Pathogen Detection Kit2 refs98/79 RevoDx Haemophilus influenzae / Human Metapneumovirus / Mycoplasma pneumoniae qPCR Kit2 refs98/79 RevoDx Moraxella catarrhalis/ Haemophilus influenzae/ Streptococcus pyogenes qPCR Kit4 refs98/79 RevoDx Respiratory-11 Pathogen Detection Kit2 refs98/79 RevoDx Respiratory-24 Pathogen Detection Kit9 refs98/79 13 others RevoDx Respiratory-24 Pathogen Detection Kit W010507050398/79 RevoDx Respiratory-24 v2.0 Pathogen Detection Kit9 refs98/79 RevoDx Respiratory-24 v3.0 Pathogen Detection Kit2 refs98/79 RevoDx Respiratory-27 Pathogen Detection Kit3 refs98/79 RevoDx Respiratory-34 Pathogen Detection Kit3 refs98/79 RevoDx Respiratory-5 Pathogen Detection Kit3 refs98/79 RevoDx Respiratory-5 version 2.0 Pathogen Detection Kit2 refs98/79 RevoDx Respiratory-5 version 3.0 Pathogen Detection Kit2 refs98/79 RevoDx Respiratory-5 version 4.0 Pathogen Detection Kit2 refs98/79 RevoDx Respiratory-6 Pathogen Detection Kit3 refs98/79 RevoDx Respiratory-6 version 3.0 Pathogen Detection Kit2 refs98/79 RevoDx Respiratory-7 Pathogen Detection Kit3 refs98/79 RevoDx Respiratory-9 Pathogen Detection Kit3 refs98/79	– 98/79	Website EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	ADEP SCREENING KIT ALT SOLUNUM YOLLARI ETKENLERİ MULTIPLLEX PCR TANI KİTİ EAR/NOSE/THROAT PANEL MAXI KIT Mini Solunum Yolu Patojenleri Panel Tipi Test Kiti RESPIRATORY BACTERIAL BASIC SCREENING KIT 11 others RESPIRATORY PATHOGENS SCREENING KIT V1 SOLUNUM PATOJENLERİ TARAMA KİTİ V1 SOLUNUM YOLU HIZLI ÇOKLU PCR KİTİ SOLUNUM YOLU PATOJENLERİ PANELİ (RPP) MIDI SOLUNUM YOLU PATOJENLERİ PANELİ (RPP) MİNİ SOLUNUM YOLU PATOJENLERİ PANELİ (RPP)MAXI SOLUNUM YOLU PATOJENLERİ TARAMA KİTİ SOLUNUM YOLU VİRÜSÜ PANELİ 21 PARÇA KİTİ RESPIRATORY TRACT VIRUS PANEL 21P KIT WHITE LUNG SYNDROME MIDDLE PANEL PCR TEST KIT WHITE LUNG SYNDROME MINI PANEL PCR TEST KIT ÜST SOLUNUM YOLLARI ETKENLERİ MULTIPLLEX PCR TANI KİTİ	B IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Bioeksen	Türkiye	Bio-Speedy® Bacterial Atypical Pneumonia Factors qPCR Kit98/79 Bio-Speedy® COVID-19/Flu RT-qPCR98/79 Bio-Speedy® Lower Respiratory Bacteria qPCR Panel5 refs98/79 Bio-Speedy® Respiratory ID-1 Kit2 refs98/79 Bio-Speedy® Respiratory ID-1 Panel98/79 9 others Bio-Speedy® Respiratory ID-2 Kit2 refs98/79 Bio-Speedy® Respiratory ID-2 Panel98/79 Bio-Speedy® Respiratory ID-3 Panel98/79 Bio-Speedy® Respiratory Tract 4T RT-qPCR Kit3 refs98/79 Bio-Speedy® Respiratory Tract RT-qPCR MX-19T Panel98/79 Bio-Speedy® Respiratory Tract RT-qPCR MX-24L Panel2 refs98/79 Bio-Speedy® Respiratory Tract RT-qPCR MX-24S Panel98/79 Bio-Speedy® Respiratory Tract RT-qPCR MX-24T Panel2 refs98/79 Bio-Speedy® Respiratory Tract Virus RT-qPCR Panel4 refs98/79	– 98/79	Website info@bioeksen.com.tr EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	Duplex Real-Time PCR Detection Kit for Influenza Virus A and Influenza Virus B3 refs98/79 Duplex Real-Time PCR Detection Kit for Mycoplasma Pneumoniae and Bordetella Pertussis2 refs98/79 Duplex Real-Time PCR Detection Kit for Mycoplasma pneumoniae and Legionella pneumophila98/79 Duplex Real-Time PCR Diagnostic Kit for Rapid Detection of Influenza Viruse A and Influenza Viruse B98/79 Duplex Real-Time PCR Kit for Detection of Mycoplasma Pneumoniae and Bordetella Pertussis98/79 8 others Multiplex Real-Time PCR Detection Kit for 17 Species of Respiratory Pathogens3 refs98/79 Multiplex Real-Time PCR Detection Kit for 6 Respiratory Viruses98/79 Triplex Real-Time PCR Detection Kit for Human metapneumovirus/Human rhinovirus /Human bocavirus98/79 Triplex Real-Time PCR Detection Kit for Klebsiella pneumoniae/Pseudomonas aeruginosa/Acinetobacter baumannii98/79 Triplex Real-time PCR Detection Kit for Middle East Respiratory Syndrome (MERS)98/79 Triplex Real-Time PCR Detection Kit for Staphylococcus aureus/Enterococcus faecalis/Enterococcus faecium98/79 Triplex Real-Time PCR Detection Kit for Streptococcus pneumonia, Haemophilus influenza and Moraxella catarrhala98/79 Triplex Real-Time PCR Kit for Detection of Escherichia coli/Enterobacter cloacae complex/ Burkholderia cepacia complex98/79	– 98/79	EUDAMED record Report an error
Bioer FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Bocavirus, Human Metapneumovirus and Rhinovirus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ12L198/79 Bocavirus, Human Metapneumovirus and Rhinovirus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ12M198/79 CentriDxTM Lower Respiratory Pathogen Panel Ⅰ BSJ62S198/79 CentriDxTM Respiratory Pathogen Panel V BSJ84S198/79 Respiratory Syncytial Virus/ Adenovirus/Parainfluenza Virus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ45L198/79 7 others Respiratory Syncytial Virus/ Adenovirus/Parainfluenza Virus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ45M198/79 SARS-CoV-2 / Respiratory Syncytial Virus / Influenza A Virus / Influenza B Virus Lyophilized Nucleic Acid Detection Kit (Fluorescence PCR) BSJ48M198/79 SARS-CoV-2 / Respiratory Syncytial Virus / Influenza A Virus / Influenza B Virus Lyophilized Nucleic Acid Detection Kit (Fluorescence PCR) BSJ48S198/79 SARS-CoV-2 / Respiratory Syncytial Virus / Influenza A Virus / Influenza B Virus Nucleic Acid Multiple Detection Kit (Fluorescence PCR) BSJ37L198/79 SARS-CoV-2 / Respiratory Syncytial Virus / Influenza A Virus / Influenza B Virus Nucleic Acid Multiple Detection Kit (Fluorescence PCR) BSJ37M198/79 Streptococcus Pneumoniae and Haemophilus Influenzae Nucleic Acid Detection Kit (Fluorescence PCR) BSJ31L198/79 Streptococcus Pneumoniae and Haemophilus Influenzae Nucleic Acid Detection Kit (Fluorescence PCR) BSJ31M198/79	– 98/79	Website ra_oversea@bioer.com.cn EUDAMED record Report an error
gerbion	Germany	alphaCube MTB/NTM/MAC98/79 alphaCube PanLegionella98/79 diarellaMTB/NTM/MAC real time PCR98/79 diarellaPanLegionella real time PCR Kit TM98/79 respiraRNA 3.0 real time RT-PCR Kit98/79 7 others respiraScreen 1 real time RT-PCR Kit98/79 respiraScreen 2 real time RT-PCR Kit98/79 respiraScreen 8plex seqc real time RT-PCR98/79 SMD lead MTC/NTM/MAC98/79 SMD lead respiraRNA 3.098/79 SMD lead respiraScreen 198/79 SMD lead respiraScreen 8plex seqc98/79	– 98/79	info@gerbion.com EUDAMED record Report an error
Certest	Spain	VIASURE Adenovirus, Metapneumovirus & Bocavirus Real Time PCR Detection Kit3 refs VIASURE C. pneumoniae, M. pneumoniae & L. pneumophila Real Time PCR Detection Kit2 refs98/79 VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit3 refs VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit for BD MAX™ System VIASURE H. influenzae, S. pneumoniae & M. catarrhalis Real Time PCR Detection Kit3 refs 5 others VIASURE Respiratory Panel VII Real Time PCR Detection Kit3 refs VIASURE Respiratory Viral Panel I Real Time PCR Detection Kit3 refs VIASURE Respiratory Virus Extended Mix Real Time PCR Detection Kit for BD MAX™ System VIASURE Rhinovirus + Enterovirus Real Time PCR Detection Kit3 refs VIASURE SARS-CoV-2, Flu & RSV Real Time PCR Detection Kit3 refs	B, C IVDR, 98/79	Website quality@certest.es EUDAMED record Report an error
Seegene FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Allplex™ PneumoBacter Assay3 refs Allplex™ Respiratory Panel 1A3 refs98/79 Allplex™ Respiratory Panel 23 refs98/79 Allplex™ Respiratory Panel 33 refs98/79 Allplex™ Respiratory Panel 43 refs98/79 5 others Allplex™ RP-Virus(I) Assay2 refs Allplex™ RP-Virus(II) Assay2 refs Allplex™ RP-Virus(III) Assay2 refs Allplex™ RV Master Assay2 refs Allplex™ TS Strep ACG&AH2 refs	B, C IVDR, 98/79	Website info@seegene.com EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi	Türkiye	Covid Flu RSV Detection and Monitoring Kit (24)3 refs98/79 Covid Flu RSV Detection and Monitoring Kit (48)3 refs98/79 Covid Flu RSV Detection and Monitoring Kit (96)3 refs98/79 Respiratory Fast Screening and Monitoring Kit (24)3 refs98/79 Respiratory Fast Screening and Monitoring Kit (48)3 refs98/79 4 others Respiratory Fast Screening and Monitoring Kit (96)3 refs98/79 Respiratory Pathogens Detection and Monitoring Kit (24)3 refs98/79 Respiratory Pathogens Detection and Monitoring Kit (48)3 refs98/79 Respiratory Pathogens Detection and Monitoring Kit (96)3 refs98/79	– 98/79	Website EUDAMED record Report an error
Cesna	Türkiye	RESPIRATORY PATHOGEN PANEL DETECTION KIT CSNMP120 RESPIRATORY PATHOGENS PANEL (RPP) MAXI RESPIRATORY PATHOGENS PANEL (RPP) MIDI RESPIRATORY PATHOGENS PANEL (RPP) MINI RESPIRATORY PATHOGENS SCREENING 24P KIT 4 others SOLUNUM YOLU PATOJENLERİ PANELİ (RPP) MIDI SOLUNUM YOLU PATOJENLERİ PANELİ (RPP) MİNİ SOLUNUM YOLU PATOJENLERİ PANELİ (RPP) MİNİ EKSTRA SOLUNUM YOLU PATOJENLERİ PANELİ (RPP)MAXI	B IVDR	Website info@cesna.com.tr EUDAMED record Report an error
Tigsun EU representative : CMC Medical Devices & Drugs SL (Spain)	China	1 test2 refs98/79 10 tests2 refs98/79 100 tests2 refs98/79 20 tests2 refs98/79 25 tests2 refs98/79 4 others 40 tests2 refs98/79 5 tests2 refs98/79 50 tests2 refs98/79 80 tests2 refs98/79	– 98/79	EUDAMED record Report an error
Vitassay	Spain	Vitassay qPCR AMB98/79 Vitassay qPCR HSM98/79 Vitassay qPCR Primary Atypical Pneumonia, high profile, 4x8-well strips98/79 Vitassay qPCR Primary Atypical Pneumonia, high profile, 8x8-well98/79 Vitassay qPCR Primary Atypical Pneumonia, high profile, 96-well plate98/79 4 others Vitassay qPCR Primary Atypical Pneumonia, low profile, 4x8-well strips98/79 Vitassay qPCR Primary Atypical Pneumonia, low profile, 8x8-well strips98/79 Vitassay qPCR Primary Atypical Pneumonia, low profile, 96-well plate98/79 Vitassay qPCR SARS-CoV-2 + Flu A + Flu B98/79	– 98/79	Website info@vitassay.com EUDAMED record Report an error
bioMérieux FDA	France	AdV/hBoV R-GENE®98/79 HCoV/HPIV R-GENE®98/79 INFLUENZA A(M) Group & H1N1 2009 R-GENE®98/79 Influenza A/B R-GENE®98/79 Legio pneumo/Cc R-GENE®98/79 3 others Rhino&EV/Cc R-GENE® RSV/hMPV R-GENE®98/79 SARS-COV-2/FLUA/FLUB/RSV R-GENE®	B IVDR, 98/79	EUDAMED record Report an error
Poly Diagnostics	Luxembourg	Poly Diagnostics Influenza A, Influenza B, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza A, Influenza B, SARS-CoV-2, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza A, Influenza B, SARS-CoV-2, RNase P, HRSV a/b Real-Time PCR kit3 refs Poly Diagnostics K. pneumoniae, M. catarrhalis, P. aeruginosa, RNase P Real-Time PCR kit3 refs Poly Diagnostics Respiratory Infection Viral Panel III Real-Time PCR kit3 refs 3 others Poly Diagnostics Respiratory Infection Viral Panel V Real-Time PCR kit3 refs Poly Diagnostics Rhinovirus/Enterovirus, Adenovirus, Bocavirus, HMPV A/B, RNase P Real-Time PCR kit3 refs Poly Diagnostics Rhinovirus/Enterovirus, Adenovirus, HRSV a/b, RNase P Real-Time PCR kit3 refs	B IVDR	Website info@polydiagnostics.com EUDAMED record Report an error
Suzhou TianLong Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Human Influenza Virus A/B / Respiratory Syncytial Virus/SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Respiratory 12 Types Virus Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Respiratory 15 Types Virus Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method-0.2mL Pre-filled)98/79 Respiratory Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Respiratory Virus Nucleic Acid Detection Kit (Fluorescence PCR Method; Pre-filled)98/79 2 others Respiratory 17 Types Pathogen Multiplex Nucleic Acid Detection Kit (Fluorescence PCR Method; Freeze-dried)98/79 Respiratory 7 Types Pathogen Multiplex Nucleic Acid Detection Kit (Fluorescence PCR Method; Freeze-dried)98/79	– 98/79	EUDAMED record Report an error
FlashDx Shenzhen EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Respiratory Panel 1.0 RP1-P10-1098/79 Respiratory Panel 1.1 RP-P10-1098/79 Respiratory Panel 2 RP2-P7-1098/79 SARS-CoV-2 Test CoV2-1098/79 SARS-CoV-2 Test CoV2-2098/79 1 other SARS-CoV-2/FluA/FluB/RSV Test Cov2P4-1098/79	– 98/79	info@flash-dx.com EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	Multiple Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Novel Coronavirus （COVID-19）Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)98/79 SARS-CoV-2, Influenza A and Influenza B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 SARS-CoV-2, Influenza Viruses and Respiratory Syncytial Virus Multiple Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 1 other Six Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs	C IVDR, 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic	Türkiye	Anatolia Geneworks6 refs Anatolia Geneworks Bosphore Respiratory Pathogens Panel Kit v122 refs98/79 Anatolia Geneworks Bosphore Respiratory Pathogens Panel Kit v53 refs98/79 Anatolia Geneworks Bosphore Respiratory Pathogens Panel Kit v73 refs98/79 Anatolia Geneworks Bosphore Respiratory Viral Basic Panel Kit v23 refs98/79	C IVDR, 98/79	Website info@anatoliagenetik.com EUDAMED record Report an error
Advanced Molecular Diagnostics EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	ZENA MAX Respiratory Panel 1 SARS-CoV-2, Influenza A and B Real Time PCR Detection Kit98/79 ZENA MAX Respiratory Panel 2 SARS-CoV-2, Influenza A & B and RSB A&B Real Time PCR Detection Kit98/79 ZENA MAX Respiratory Panel 3 SARS-CoV-2, Influenza A&B and H1N1 Real Time PCR Detection Kit98/79 ZENA MAX Respiratory Panel 4 SARS-CoV-2 and Coronavirus (HKU1, NL63, OC43, 229E)98/79	– 98/79	Website info@am-diagnostics.co.uk EUDAMED record Report an error
Immundiagnostik FDA	Germany	MutaPlex® RespiraScreen 1, PCR2 refs98/79 MutaPlex® RespiraScreen 2 DIFF, PCR3 refs98/79 MutaPLEX® RespiraScreen 4 DIFF seqc., PCR3 refs98/79 MutaPLEX® RespiraSys 1, PCR2 refs98/79	– 98/79	Website info@immundiagnostik.com EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	MultNAT Pneumonia Panel98/79 MultNAT Pneumonia Panel 22 refs98/79 MultNAT Respiratory Panel2 refs MultNAT Respiratory Panel 298/79	C IVDR, 98/79	Website service@bioustar.com EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany)	China	Cowingene Influenza A/B and RSV Detection Kit98/79 Cowingene Respiratory Pathogen Panel 21 Detection Kit98/79 Cowingene Respiratory Pathogen Panel Detection Kit98/79	– 98/79	Website EUDAMED record Report an error
Diasia FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	100 Tests/kit98/79 25 Tests/kit98/79 50 Tests/kit98/79	– 98/79	Website EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	14 Kinds of Respiratory Pathogens Combined Nucleic Acid Detection Kit (Fluorescence PCR)98/79 4 Kinds of Respiratory Viruses Nucleic Acid Detection Kit (Fluorescence PCR)98/79 SARS-CoV-2, Respiratory Syncytium, and Influenza A&B Antigen Combined Detection Kit(Latex Method)98/79	– 98/79	marketing@hongweitest.com EUDAMED record Report an error
Kingcreate EU representative : Kingsmead Service B.V. (Netherlands)	China	Respiratory Pathogens Detection Kit Specification A:1 test/tube, 24 tests/box98/79 Respiratory Pathogens Detection Kit Specification B: 8 tests/strip,24 tests/box98/79 Respiratory Pathogens Detection Kit Specification C: 8 tests/strip,24 tests/box98/79	– 98/79	EUDAMED record Report an error
Kogene EU representative : Obelis s.a. (Belgium)	South Korea	PowerChek™ 18 RV Panel Kit98/79 PowerChek™ Adenovirus / Bocavirus Real-time PCR Kit98/79 PowerChek™ RSV A & B/HMV Real-time PCR Kit98/79	– 98/79	Website info@kogene.co.kr EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	APA01-AOG48E; APA01-AOG96E; APA01D-AOG48E; APA01D-AOG96E98/79 CRTI701A-AOG4E98/79 Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(Flowcytometry Fluorescence Hybridization Method)98/79	– 98/79	EUDAMED record Report an error
Progenie molecular S.L.U	Spain	RealCycler BHOLPP-ABI3298/79 RealCycler BHOLPP-UX98/79 RealCycler BORDETEL-P1-ST198/79	– 98/79	EUDAMED record Report an error
Shenzhen Chenghui Medical Technology EU representative : HUMISS TRADING S. L. (Spain)	China	Lower Respiratory Tract Pathogen and Antimicrobial Resistance Gene Nucleic Acid Detection Kit 1.198/79 Respiratory Tract Pathogen Test Kit 2.198/79 Upper Respiratory Tract Pathogen Nucleic Acid Detection Kit (Fluorescent PCR-Chip Method)	B IVDR, 98/79	EUDAMED record Report an error
Ablsa	Luxembourg	UltraGene Assay Respiratory pathogens 21 (32 tests)98/79 UltraGene Assay Respiratory pathogens 21 (64 tests)98/79	– 98/79	Website contact@ablsa.com EUDAMED record Report an error
Aitbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	Singapore	30027598/79 30027698/79	– 98/79	Website EUDAMED record Report an error
BioFire Diagnostics FDA EU representative : bioMérieux SA (France)	United States	BioFire® Respiratory Panel 2.1 plus (RP2.1 plus) BIOFIRE® FILMARRAY® Pneumonia Panel plus2 refs	D IVDR	EUDAMED record Report an error
Cepheid FDA EU representative : Cepheid AB (Sweden)	United States	Xpert®98/79 Xpert® Xpress CoV-2/Flu/RSV plus98/79	– 98/79	Website EUDAMED record Report an error
ElitechGroup FDA	Italy	Respiratory Bacterial PLUS - ELITe Positive Control2 refs Respiratory Viral PLUS ELITe MGB® Kit98/79	C IVDR, 98/79	Website EUDAMED record Report an error
Guangzhou Biotron Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Respiratory 12-Pathogen Nucleic Acid Detection Kit (Fluorescent PCR Melting Curve Method)2 refs98/79 Respiratory 15-Pathogen Nucleic Acid Detection Kit (Fluorescent PCR Melting Curve Method)2 refs98/79	– 98/79	EUDAMED record Report an error
Guangzhou Deaou Gene Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	4 tests/kit2 refs98/79 8 tests/kit2 refs98/79	– 98/79	EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : VidaQuick Biotech S.L. (Spain)	China	Influenza A/B and RSV RT-qPCR Kit98/79 SARS-CoV-2, Influenza A/B and RSV RT-qPCR Kit98/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Hangzhou Zhunxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	HA-01098/79 HA-02298/79	– 98/79	EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	CRTI7C01A-AHG4E98/79 Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(Flowcytometry Fluorescence Hybridization Method)98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium)	United States	Panther Fusion AdV/hMPV/RV Assay2 refs Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay2 refs	B IVDR	EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain)	South Korea	Lower Respiratory Pathogens Multiplex Detection Kit MLR-19E98/79 Respiratory Pathogens Multiplex Detection Kit MUR-24E98/79	– 98/79	EUDAMED record Report an error
Igenesis Shanghai EU representative : CMC Medical Devices & Drugs SL (Spain)	China	12 reactions/kit4 refs98/79 Influenza A Virus / Influenza B Virus/Respiratory Syncytial Virus Diagnostic Kit (PCR-Fluorescence)98/79	– 98/79	support@igenesisbio.com EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Medunion S.L. (Spain) and 1 other	China	2019-Novel Coronavirus, Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based Real-time PCR Assay)98/79 Multi Respiratory Pathogen Real Time PCR Detection Kit5 refs98/79	– 98/79	EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain)	China	S.p/L.p/S.aureus/Kpn/M.P Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79 S.p/L.p/S.aureus/M.P Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79	– 98/79	EUDAMED record Report an error
PentaBase	Denmark	CoviFLU98/79 RespiDetect98/79	– 98/79	Website info@pentabase.com EUDAMED record Report an error
Pilotgene EU representative : Medunion S.L. (Spain)	China	RP0198/79 TB0198/79	– 98/79	EUDAMED record Report an error
R-Biopharm FDA	Germany	RIDA®GENE CAP Bac3 refs RIDA®UNITY CAP Bac	C IVDR	Website EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	14 RP Panel I98/79 20 RP Panel I98/79	– 98/79	Website EUDAMED record Report an error
Vazyme EU representative : Obelis s.a. (Belgium) and 1 other	China	Logilet Respiratory Pathogen Panel VD101198/79 Logilet Respiratory/Sore Throat (R/ST) Test Panel DUR01M98/79	– 98/79	EUDAMED record Report an error
altona Diagnostics FDA	Germany	FlexStar® FLU Type & RSV RT-PCR Detection Mix 1.5	B IVDR	info@altona-diagnostics.com EUDAMED record Report an error
Atlas Link Technology FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	China	Respiratory Antigen Multiple Test Kit C21343 refs	C IVDR	Website EUDAMED record Report an error
Credo Diagnostics Biomedical Pte Taiwan Branch EU representative : MedNet EC-REP GmbH (Germany)	Taiwan	VitaPCR Influenza/SARS-CoV-2 (Flu/SC2) Assay98/79	– 98/79	service@credodxbiomed.com EUDAMED record Report an error
Elisabeth	Czechia	EliGene® COVID19 Triple RIC RT98/79	– 98/79	Website info@elisabeth.cz EUDAMED record Report an error
Genemind EU representative : Medunion S.L. (Spain)	China	GeneMind 96 tests/kit98/79	– 98/79	regulatoryaffairs@genemind.com EUDAMED record Report an error
Geneproof	Czechia	GeneProof Flu Multiplex PCR Kit2 refs98/79	– 98/79	Website support@geneproof.com EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium)	India	Comprehensive Respiratory Virus Panel G2MCRVP1700198/79	– 98/79	Website EUDAMED record Report an error
Genetree EU representative : Obelis s.a. (Belgium)	South Korea	NamuPlex™ GNT-2013-1	C IVDR	Website ra@genetree.co.kr EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Canada	Influenza A/ B and Respiratory Syncytial Virus Detection Kit (Fluorescence PCR) AFR0198/79	– 98/79	sales@orientgene.com EUDAMED record Report an error
Jiangsu Q-Array EU representative : Caretechion GmbH (Germany)	China	Bordetella pertussis and Mycoplasma pneumoniae Nucleic Acid Multiplex Detection Kit (Fluorescence PCR)98/79	– 98/79	EUDAMED record Report an error
Luminex Molecular Diagnostics FDA EU representative : DiaSorin Italia S.p.A. (Italy)	Canada	NxTAG® Respiratory Pathogen Panel v2	B IVDR	Website regulatoryaffairs@luminexcorp.com EUDAMED record Report an error
Luminexcorp FDA EU representative : DiaSorin Italia S.p.A. (Italy)	United States	LIAISON PLEX® Respiratory Flex Assay	C IVDR	Website regulatoryaffairs@luminexcorp.com EUDAMED record Report an error
Qiagen FDA	Germany	QIAstat-Dx Respiratory SARS-CoV-2 Panel2 refs	C IVDR, 98/79	Website info@qiagen.com EUDAMED record Report an error
Reetoo EU representative : Umedwings Netherlands B.V. (Netherlands)	China	Influenza & SARS-CoV-2 Antigen Combo Test Kit（Colloidal Gold Immunochromatographic Assay)98/79	– 98/79	Website service@reetoo.com.cn EUDAMED record Report an error
Suny (Xiamen) Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	BOIRON COVID-19/Grippe Rapid Antigen Test98/79	– 98/79	EUDAMED record Report an error
Vacure EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Multiple-type Respiratory Pathogen Nucleic Acid Kit (Fluorescent PCR)98/79	– 98/79	EUDAMED record Report an error
Vircell	Spain	SARS-CoV-2/FluA/FluB/RSV REAL TIME PCR KIT RTPCR0212 refs	B IVDR	EUDAMED record Report an error
Viuick EU representative : SUNGO Europe B.V. (Netherlands)	China	VIUICK Diagnostic Kit for Influenza virus/Respiratory syncytial virus/2019-nCoV RNA (Real-Time PCR Method)98/79	– 98/79	EUDAMED record Report an error
Yanengbio EU representative : Obelis s.a. (Belgium)	China	Respiratory Pathogens Combo Testing Kit98/79	– 98/79	Website EUDAMED record Report an error
Zybio FDA EU representative : QbD RepS BV (Belgium)	China	Molaccu Mycoplasma pneumoniae and Chlamydia pneumoniae Nucleic Acid Detection Kit (Real-time PCR)3 refs	C IVDR	PMS@zy-ivd.com EUDAMED record Report an error
Mobidiag No model still on the market	Finland	Amplidiag COVID-19 Kit98/79 (no longer marketed) Amplidiag RESP-4 Kit98/79 (no longer marketed) Novodiag COVID-1998/79 (no longer marketed) Novodiag RESP-498/79 (no longer marketed)	– 98/79	Website sales.mob@hologic.com EUDAMED record Report an error
Arcdia No model still on the market	Finland	mariPOC® Quick combi test plate (no longer marketed) mariPOC® RTI combi test plate (no longer marketed)	A IVDR	Website office@arcdia.com EUDAMED record Report an error
Genetic Signatures FDA EU representative : mdi Europa GmbH (Germany) No model still on the market	Australia	EasyScreen Respiratory Pathogen Detection Kit (RP007)98/79 (no longer marketed) EasyScreen® SARS CoV-2 Detection Kit98/79 (no longer marketed)	– 98/79	Website RAQA@geneticsignatures.com EUDAMED record Report an error
Raingene EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	FluA/FluB/RSV Virus Nucleic Acid Detection Kit 10tests/kit, 20tests/kit98/79 (no longer marketed) Multiply Respiratory Pathogen Virus Nucleic Acid Detection Kit 10tests/kit，20tests/kit98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Innobiochips No model still on the market	France	SirYus Covidiag2 refs98/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.

Didn't find it?

Related categories