Infectious diseasesMultiple parameters - (infect. immunology/NAT)Multiple viruses panels

Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents

EMDN code W0105070304

61 manufacturers, 151 models including 148 on the market, 15 countries

On the market in Models on the market only Manufacturer country

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 EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	6 RP Panel I98/79 6 RP Panel II98/79 HRV/RSV/HMPV Multiplex Real Time RT-PCR Kit98/79 Human Parainfluenza Virus Type 1 Real Time RT-PCR Kit98/79 Human Parainfluenza Virus Type 2 Real Time RT-PCR Kit98/79 17 others Human Parainfluenza Virus Type 3 Real Time RT-PCR Kit98/79 Human Parainfluenza Virus Type 4 Real Time RT-PCR Kit98/79 Influenza Virus A Real Time RT-PCR Kit98/79 Influenza Virus A&B Real Time RT-PCR Kit98/79 Influenza Virus A,B&C Real Time RT-PCR Kit98/79 Influenza Virus B Real Time RT-PCR Kit98/79 Influenza Virus B Typing Real Time RT-PCR Kit98/79 Influenza Virus C Real Time RT-PCR Kit98/79 Influenza Virus H1 Real Time RT-PCR Kit98/79 Influenza Virus H3 Real Time RT-PCR Kit98/79 Influenza Virus A H1&H3 Real Time RT-PCR Kit98/79 N1 Gene of Influenza Virus A Real Time RT-PCR Kit98/79 N2 Gene of Influenza Virus A Real Time RT-PCR Kit98/79 N3 Gene of Influenza Virus A Real Time RT-PCR Kit98/79 N7 Gene of Influenza Virus A Real Time RT-PCR Kit98/79 New influenza A virus Real Time RT-PCR Panel98/79 New influenza A virus（H1N1） Real Time RT-PCR Kit98/79	– 98/79	Website EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain)	China	SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Control98/79 SARS-CoV-2 Antibody Test Kit (Colloidal Gold Chromatographic Immunoassay)98/79 SARS-CoV-2 Antibody Test Kit (Fluorescence Immunoassay)98/79 SARS-CoV-2 Antigen Test Control98/79 SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)(Saliva)98/79 7 others SARS-CoV-2 Antigen Test Kit (Fluorescence Immunoassay)98/79 SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Fluorescence Immunoassay)98/79 SARS-CoV-2 Neutralizing Antibody Test Kit (Colloidal Gold Chromatographic Immunoassay)98/79 SARS-CoV-2 Neutralizing Antibody Test Kit (Fluorescence Immunoassay)98/79 SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay)3 refs98/79 SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay)98/79 SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay)98/79	– 98/79	EUDAMED record Report an error
Healgen EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	101A0227EY98/79 ACAB01-AHG48E; ACAB01-AHG96E98/79 ACAB04D-BHG48E98/79 ACOV01-AHG48E; ACOV01-AHG96E98/79 ACOV03-AHG48E; ACOV03-AHG96E; ACOV03D-AHG48E; ACOV03D-AHG96E98/79 4 others ACOV03D-AHG48E; ACOV03D-AHG96E98/79 AFR01-AHG48E; AFR01-AHG96E; AFR01D-AHG48E; AFR01D-AHG96E98/79 CRTI7A01A-AHG4E98/79 CRTI7B01A-AHG4E98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Orientgene EU representative : CMC Medical Devices & Drugs SL (Spain)	China	101A0227EY98/79 ACOV03-AOG48E; ACOV03-AOG96E; ACOV03D-AOG48E; ACOV03D-AOG96E98/79 CFFCR01A-AOG4E98/79 CRTI601A-AOG4E98/79 CRTI7B01A-AOG4E98/79 1 other CRTI7C01A-AOG4E98/79	– 98/79	EUDAMED record Report an error
Ablsa	Luxembourg	UltraGene Assay Combo 4 Screening V2.X (1000 tests)98/79 UltraGene Assay Combo 4 Screening V2.X (50 tests)98/79 UltraGene Assay FLU/HRSV (32 tests)98/79 UltraGene Assay FLU/HRSV (64 tests)98/79	– 98/79	Website contact@ablsa.com EUDAMED record Report an error
Aitbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	Singapore	30014398/79 30014498/79 30026798/79 30026898/79	– 98/79	Website EUDAMED record Report an error
Anhui Deepblue Medical Technology EU representative : Luxus Lebenswelt GmbH (Germany) and 2 others	China	CESONO：Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) Cassette3 refs COVID-19/FluA/FluB/RSV Antigen Combo Test Kit(LFA) Cassette98/79 Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) Cassette2 refs98/79 Influenza A+B Antigen Test Kit (Colloidal Gold) Cassette98/79	C IVDR, 98/79	sales@dbluemedical.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	Quadruplex Real-Time PCR Detection Kit for SARS-CoV-2 and Influenza Viruses A/B98/79 Quadruplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N and Influenza Viruses A/B3 refs98/79 Quadruplex Real-Time PCR Detection Kit for SARS-CoV-2, Influenza Viruses A/B and Respiratory Syncytial Virus98/79 Quadruplex Real-Time PCR Diagnostic Kit for Rapid Detection of 2019-nCoV and Influenza Viruses A/B98/79	– 98/79	EUDAMED record Report an error
Kogene EU representative : Obelis s.a. (Belgium)	South Korea	PowerChek™ Influenza A&B, RSV Multiplex Real-time PCR Kit98/79 PowerChek™ SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit2 refs98/79 PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit98/79 PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit II3 refs98/79	– 98/79	Website info@kogene.co.kr EUDAMED record Report an error
Limingbio EU representative : Wellkang Ltd (Northern Ireland)	China	StrongStep® Influenza A/B & RSV Multiplex Real-Time PCR Kit 96 Tests/box98/79 StrongStep® Influenza A/B Multiplex RT-qPCR Kit 96 Tests/box98/79 StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detection for three genes) 96 Tests/box98/79 StrongStep® SARS-CoV-2 & Influenza A/B Multiplex Real-Time PCR Kit 96 Tests/box98/79	– 98/79	Website sales@limingbio.com EUDAMED record Report an error
3Bblackbio EU representative : Wellkang Ltd (Northern Ireland)	India	TRUPCR® Influenza A/B & RSV with SARS-CoV-2 RT qPCR Kit3 refs TRUPCR® SARS-CoV-2 RT qPCR Kit TRUPCRÂ® Flu Panel with RSV detection Kit3 refs	B IVDR	Website info@3bblackbio.com EUDAMED record Report an error
Abiores Technology (Beijing) EU representative : Sungo Cert GmbH (Germany) and 1 other	China	Influenza A Virus and Influenza B Virus RNA Diagnostic Kit (Fluorescence PCR) Cassette98/79 Respiratory Syncytial Virus RNA Diagnostic Kit (Fluorescence PCR) Cassette98/79 SARS-CoV-2(COVID-19) Fluorescence PCR Kit Cassette98/79	– 98/79	EUDAMED record Report an error
Genmark	Türkiye	geneMAP Respiratory Master Panel, 50T98/79 geneMAP Respiratory Viral Panel 2 (2019-nCoV, Inf A/B, RSV A/B),100T98/79 geneMAP Respiratory Viral Panel 3 (2019-nCoV, Inf A/B),100T98/79	– 98/79	Website info@genmark.com.tr EUDAMED record Report an error
Goldsite EU representative : CMC Medical Devices & Drugs SL (Spain)	China	SARS-CoV-2 & Influenza A/B & RSV Antigen Kit (Colloidal Gold)3 refs98/79 SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing)4 refs98/79 SARS-CoV2 & Influenza A/B Antigen Kit (Colloidal Gold)3 refs98/79	– 98/79	Website export@goldsite.com.cn EUDAMED record Report an error
HEALSTONE Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	Canada	Rapid Respiratory Syncytial Virus RNA Test RRSV0198/79 SARS-CoV-2 & Influenza A/B Detection Kit (Direct Fluorescence PCR) ACAB0198/79 SARS-CoV-2 & Omicron Variants Detection Kit (Fluorescence PCR) ACOV0898/79	– 98/79	sales@orientgene.com EUDAMED record Report an error
Idilbiotech	Türkiye	RevoDx Flu A / Flu B / RSV / SARS-CoV-2 qPCR Kit2 refs98/79 RevoDx Flu A&B / RSV / SARS-CoV-2 qPCR Kit2 refs98/79 RevoDx Flu A&B / SARS-CoV-2 qPCR Kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Vivachek EU representative : Lotus NL B.V. (Netherlands)	China	Influenza A+B Ag Test Kit (FIA) VID3698/79 Influenza A+B/RSV Test Kit (FIA) VID11198/79 VivaDiag Influenza A+B/RSV Test Kit (FIA) VID11198/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Bioperfectus EU representative : MedNet EC-REP GmbH (Germany)	China	Respiratory Virus Panel (7) Real Time PCR Kit JC150701NW-24T98/79 Respiratory Virus Panel (7) Real Time PCR Kit JC150701NW-48T98/79	– 98/79	EUDAMED record Report an error
Clongene EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Influenza A/B & RSV RT-PCR Test Kit IRP53Na98/79 SARS-CoV-2 & Influenza A/B RT-PCR Test Kit IID53Na98/79	– 98/79	Website marketing@clongene.com EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany)	China	Cowingene Respiratory Pathogen Panel Pro Detection Kit98/79 Cowingene SARS-CoV-2 & Influenza A/B Detection Kit98/79	– 98/79	Website EUDAMED record Report an error
Dianabiotech	Czechia	DBdirect™ Respiratory panel 1: SARS-CoV-2/Flu/RSV2 refs98/79 RT-PCR Respiratory panel 1: SARS-CoV-2/Flu/RSV2 refs98/79	– 98/79	Website info@dianabiotech.com EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium)	India	CoVFlu One Step RT PCR Kit G2M27272198/79 RCP-Q comprehensive Real Time PCR Kit for Respiratory G2M80352198/79	– 98/79	Website EUDAMED record Report an error
Hangzhou Danwei Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	ACAB01,ACAB0298/79 ACOV03,ACOV03D98/79	– 98/79	ra.danwei@danwei-bio.com EUDAMED record Report an error
Progenie molecular S.L.U	Spain	RealCycler COROFLUR-ABI3298/79 RealCycler COROFLUR-UX98/79	– 98/79	EUDAMED record Report an error
Tellgencorp EU representative : Medunion S.L. (Spain)	China	SARS-CoV-2 /Influenza A/Influenza B/RSV Nucleic Acid Detection Kit98/79 SARS-CoV-2 /Influenza A/Influenza B/RSV/ADV/MP/MPV Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79	– 98/79	Website sales@tellgen.com EUDAMED record Report an error
Vitassay	Spain	Vitassay qPCR Flu + RSV + SARS CoV-2 N1/298/79 Vitassay qPCR Flu A + Flu B + RSV98/79	– 98/79	Website info@vitassay.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	SARS-CoV-2/FLU DETECTION KIT SARS-COV-2/FLU/RSV DETECTION KIT	B IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
ZeptoMetrix EU representative : Emergo Europe B.V. (Netherlands)	United States	NATtrol™ Flu/RSV/SARS-CoV-2 Negative Control NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control	B IVDR	Website EUDAMED record Report an error
1drop EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	1copy™ COVID-19/FluA/FluB/RSV qPCR Kit M2598/79	– 98/79	Website sales@1drop.co.kr EUDAMED record Report an error
Abbott EU representative : Abbott GmbH (Germany)	United States	ALINITY M RESP-4-PLEX4 refs	B IVDR	EUDAMED record Report an error
Appolon Bioteck	France	RespiGUARD4plex	B IVDR	Website contact@appolonbioteck.com EUDAMED record Report an error
Cepheid EU representative : Cepheid AB (Sweden)	United States	Xpert®98/79	– 98/79	Website EUDAMED record Report an error
Cesna	Türkiye	SARS-CoV-2/FLU/RSV DETECTION KIT	B IVDR	Website info@cesna.com.tr EUDAMED record Report an error
Credo Diagnostics Biomedical Pte Taiwan Branch EU representative : MedNet EC-REP GmbH (Germany)	Taiwan	VitaPCR Flu/RSV Assay98/79	– 98/79	service@credodxbiomed.com EUDAMED record Report an error
DiaSorin EU representative : DiaSorin Italia S.p.A. (Italy)	United States	Simplexa™ COVID-19 / Flu A/B & RSV Direct	B IVDR	Website ivdr_dsm@diasorin.com EUDAMED record Report an error
ELITechGroup	Italy	SARS-CoV-2 PLUS - ELITe Positive Control SARS-CoV-2 PLUS ELITe MGB® Kit2 refs	B IVDR	Website EUDAMED record Report an error
Eurobio Scientific	France	EurobioPlex FluCoSyn EBX-0425 refs98/79	– 98/79	reglementaire@eurobio-scientific.com EUDAMED record Report an error
Fanttest EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	25 tests/kit98/79	– 98/79	info@fanttest.com EUDAMED record Report an error
GeneMatrix EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	NeoPlex™ RV-Panel B Detection Kit NR042 refs98/79	– 98/79	Website support@genematrix.net EUDAMED record Report an error
Genetree EU representative : Obelis s.a. (Belgium)	South Korea	NamuPlex™ Q016A98/79	– 98/79	Website ra@genetree.co.kr EUDAMED record Report an error
GenMark Diagnostics EU representative : Roche Diagnostics GmbH (Germany)	United States	cobas® eplex respiratory pathogen panel 3 (RP3)	B IVDR	regulatory.rmd_international@roche.com EUDAMED record Report an error
Getein EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit	C IVDR	EUDAMED record Report an error
Hain Lifescience	Germany	FluoroType® SARS-CoV-2/Flu/RSV VER 1.098/79	– 98/79	EUDAMED record Report an error
Hunan Kangxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Influenza A/B & RSV Antigen Kit (Microfluidic Fluorescent Immunoassay)98/79	– 98/79	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
Jiangsu Q-Array EU representative : Caretechion GmbH (Germany)	China	Influenza A/B & RSV Nucleic Acid Multiplex Detection Kit(Fluorescence PCR)5 refs98/79	– 98/79	EUDAMED record Report an error
KH Medical EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	RADI FAST Flu-SC2-RSV Detection Kit98/79	– 98/79	Website info@khmedical.co.kr EUDAMED record Report an error
Operon	Spain	Real SARS-CoV-2/Flu/RSV 5.237.XXX.88.ZZZ98/79	– 98/79	Website infoeudamed@operon.es EUDAMED record Report an error
Pluslife EU representative : Kingsmead Service B.V. (Netherlands)	China	Influenza A/Influenza B/RSV Nucleic Acid Test Card98/79	– 98/79	Website ra@pluslife.com EUDAMED record Report an error
Sansure EU representative : Obelis s.a. (Belgium)	China	Influenza A/B Virus and Respiratory Syncytial Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
SD Biosensor EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	STANDARD™ M10 Flu/RSV/SARS-CoV-2 M10-CVFR-0198/79	– 98/79	Website EUDAMED record Report an error
Seegene EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay2 refs98/79	– 98/79	Website info@seegene.com EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Flu A Flu B+RSV+ ADV Rapid Detection Kit(Colloidal Gold) 25 Tests/kit98/79	– 98/79	Website sales@szzijian.com EUDAMED record Report an error
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Detection Kit for Influenza A Virus, Influenza B Virus and Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing)98/79	– 98/79	sales@singuway.com EUDAMED record Report an error
SpeeDx EU representative : MedEnvoy Global BV (Netherlands)	Australia	PlexPCR RespiVirus (610) 1.03 refs	B IVDR	Website regulatory@speedx.com.au EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	MultNAT SARS-CoV-2/Flu and RSV PCR Assay	B IVDR	Website service@bioustar.com EUDAMED record Report an error
Vela Operations Singapore Pte EU representative : Vela Diagnostics Germany GmbH (Germany)	Singapore	ViroKey Flu A/B & RSV RT-PCR Extension Kit 30107498/79	– 98/79	Website infoAPAC@veladx.com EUDAMED record Report an error
Vitrosens	Türkiye	ChainFor™ SARS-CoV-2/FLU/RSV Genotyping qPCR Kit3 refs	B IVDR	Website info@vitrosens.com EUDAMED record Report an error
Wwhsbio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	SARS-CoV-2 Antigen Rapid Test Kit（Colloidal Gold） 25Tests/Kit98/79	– 98/79	Website info@wwhsbio.com EUDAMED record Report an error
Zhuhai Shineway Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	SW-RCA-0198/79	– 98/79	Website EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	China	Adeno/RSV Ag Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed) COVID-19/Influenza Ag Combo Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed) COVID-19/Influenza Ag Combo Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

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