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

Respiratory syncytial virus (rsv) - NA reagents

EMDN code W0105040505

30 manufacturers, 38 models including 38 on the market, 11 countries

On the market in Manufacturer country

Manufacturers registered in Europe (EUDAMED) 30

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
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	SOLUNUM SİNSİTİYAL VİRÜSÜ (RSV) -A,B TESPİT KİTİ SOLUNUM SİNSİTİYAL VİRÜSÜ (RSV) – B TESPİT KİTİ SOLUNUM SİNSİTİYAL VİRÜSÜ (RSV) – TEST KİTİ	B IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Cesna	Türkiye	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
Daan Gene EU representative : MDSS GmbH (Germany)	China	Single tube, 10 tests/kit2 refs98/79 Single tube, 20 tests/kit2 refs98/79	– 98/79	EUDAMED record Report an error
Gold Standard Diagnostics FDA	Germany	RSV A, RSV B PRSV616198/79 RSV A, RSV B PRSV616498/79	– 98/79	info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Hecin EU representative : Share info GmbH (Germany)	China	AccuProbe RSV PCR Kit3 refs HCPlex RSV PCR Kit3 refs	B IVDR	EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Respiratory Syncytial Virus (RSV) Typing A &B Real Time RT-PCR Kit2 refs98/79 Respiratory Syncytial Virus(RSV) Real Time RT-PCR Kit98/79	– 98/79	Website EUDAMED record Report an error
Suzhou TianLong Biotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	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	– 98/79	EUDAMED record Report an error
altona Diagnostics FDA	Germany	RealStar® RSV RT-PCR Kit 3.098/79	– 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 Respiratory Syncytial Virus98/79	– 98/79	EUDAMED record Report an error
Bgi	Denmark	BGI 50 tests/kit98/79	– 98/79	Website EUDAMED record Report an error
Bioer FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Respiratory Syncytial Virus Type A / Type B Nucleic Acid Detection Kit (Fluorescent RT- PCR) BSJ05S1, BSJ05M1, BSJ05L13 refs	B IVDR	Website ra_oversea@bioer.com.cn EUDAMED record Report an error
Certest	Spain	VIASURE RSV A + B Real Time PCR Detection Kit3 refs	B IVDR	Website quality@certest.es EUDAMED record Report an error
GenDx FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	GENEYE® Respiratory Syncytial Virus（RSV）ERA Assay98/79	– 98/79	EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Canada	Rapid Human Adenovirus DNA Test RADV0198/79	– 98/79	sales@orientgene.com EUDAMED record Report an error
Idilbiotech	Türkiye	RevoDx RSV qPCR Kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Ingenetix	Austria	ViroReal® Kit RSV (A & B)98/79	– 98/79	Website office@ingenetix.com EUDAMED record Report an error
Iontek	Türkiye	Fluorion RSV QLP 1.0 Real-Time PCR Kit98/79	– 98/79	Website EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany)	China	Respiratory Syncytial Virus (A/B) Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	EUDAMED record Report an error
KH Medical EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	RADI FAST RSV A/B Detection Kit98/79	– 98/79	Website info@khmedical.co.kr EUDAMED record Report an error
Poly Diagnostics	Luxembourg	Poly Diagnostics HRSV a/b, RNase P Real-Time PCR kit3 refs	B IVDR	Website info@polydiagnostics.com EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	Respiratory Syncytial Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Respiratory Syncytial Virus IgM (RSV-IgM) Detection Kit(CLIA) 50 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 Respiratory Syncytial Virus RNA (PCR Fluorescence Probing)98/79	– 98/79	sales@singuway.com EUDAMED record Report an error
TIB MOLBIOL Syntheselabor	Germany	ModularDx Kit RSV-A/B98/79	– 98/79	Website EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	EasyNAT Rapid RSV Assay	B IVDR	Website service@bioustar.com EUDAMED record Report an error
Vela Operations Singapore Pte FDA EU representative : Vela Diagnostics Germany GmbH (Germany)	Singapore	Sentosa SA RSV RT-PCR Test 11132698/79	– 98/79	Website infoAPAC@veladx.com EUDAMED record Report an error
Vitassay	Spain	Vitassay qPCR RSV A + RSV B98/79	– 98/79	Website info@vitassay.com EUDAMED record Report an error
Vitrosens	Türkiye	LyoSens RSV A + B qPCR Kit LYO148WS9698/79	– 98/79	Website info@vitrosens.com EUDAMED record Report an error
Viuick EU representative : SUNGO Europe B.V. (Netherlands)	China	VIUICK98/79	– 98/79	EUDAMED record Report an error
ZeptoMetrix FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	NATtrol™ RSV Positive Control	B IVDR	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.

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