ReagentsInfectious diseasesOther virology tests (infect. immunology/NAT)

Virology reagents - other

EMDN code W01050499

27 manufacturers, 95 models including 94 on the market, 7 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 27

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
Beijing Kinghawk Pharmaceutical EU representative : Medunion S.L. (Spain)	China	Brucella Antibody Rapid Test Kit (Lateral Flow Immunoassay) 10 tests/kit98/79 Brucella Antibody Rapid Test Kit (Lateral Flow Immunoassay) 25 tests/kit98/79 Brucella Antibody Rapid Test Kit (Lateral Flow Immunoassay) 40 tests/kit98/79 Brucella Antibody Rapid Test Kit (Lateral Flow Immunoassay) 50 tests/kit98/79 Chikungunya IgG/IgM Rapid Test Kit (Lateral Flow Immunoassay) 10 tests/kit98/79 46 others Chikungunya IgG/IgM Rapid Test Kit (Lateral Flow Immunoassay) 25 tests/kit98/79 Chikungunya IgG/IgM Rapid Test Kit (Lateral Flow Immunoassay) 40 tests/kit98/79 Chikungunya IgG/IgM Rapid Test Kit (Lateral Flow Immunoassay) 50 tests/kit98/79 Chikungunya Virus Antigen Rapid Test Kit (Lateral Flow Immunoassay) 10 tests/kit98/79 Chikungunya Virus Antigen Rapid Test Kit (Lateral Flow Immunoassay) 25 tests/kit98/79 Chikungunya Virus Antigen Rapid Test Kit (Lateral Flow Immunoassay) 40 tests/kit98/79 Chikungunya Virus Antigen Rapid Test Kit (Lateral Flow Immunoassay) 50 tests/kit98/79 Dengue Virus IgM/IgG Antibody Test Kit (Lateral Flow Immunoassay) 10 tests/kit98/79 Dengue Virus IgM/IgG Antibody Test Kit (Lateral Flow Immunoassay) 25 tests/kit98/79 Dengue Virus IgM/IgG Antibody Test Kit (Lateral Flow Immunoassay) 40 tests/kit98/79 Dengue Virus IgM/IgG Antibody Test Kit (Lateral Flow Immunoassay) 50 tests/kit98/79 Dengue Virus NS1 Antigen Rapid Test Kit (Lateral Flow Immunoassay) 10 tests/kit98/79 Dengue Virus NS1 Antigen Rapid Test Kit (Lateral Flow Immunoassay) 25 tests/kit98/79 Dengue Virus NS1 Antigen Rapid Test Kit (Lateral Flow Immunoassay) 40 tests/kit98/79 Dengue Virus NS1 Antigen Rapid Test Kit (Lateral Flow Immunoassay) 50 tests/kit98/79 Influenza A/B Virus Antigen Rapid Test Kit (Lateral Flow Immunoassay) 10 tests/kit98/79 Influenza A/B Virus Antigen Rapid Test Kit (Lateral Flow Immunoassay) 25 tests/kit98/79 Influenza A/B Virus Antigen Rapid Test Kit (Lateral Flow Immunoassay) 40 tests/kit98/79 Influenza A/B Virus Antigen Rapid Test Kit (Lateral Flow Immunoassay) 50 tests/kit98/79 Leptospira IgG/IgM Rapid Test Kit (Lateral Flow Immunoassay) 10 tests/kit98/79 Leptospira IgG/IgM Rapid Test Kit (Lateral Flow Immunoassay) 40 tests/kit98/79 Leptospira IgG/IgM Rapid Test Kit (Lateral Flow Immunoassay) 50 tests/kit98/79 Malaria Pf/Pan Antigen Rapid Test Kit (Lateral Flow Immunoassay) 10 tests/kit98/79 Malaria Pf/Pan Antigen Rapid Test Kit (Lateral Flow Immunoassay) 25 tests/kit98/79 Malaria Pf/Pan Antigen Rapid Test Kit (Lateral Flow Immunoassay) 40 tests/kit98/79 Malaria Pf/Pan Antigen Rapid Test Kit (Lateral Flow Immunoassay) 50 tests/kit98/79 Monkeypox Virus Antigen Rapid Test Kit (Lateral Flow Immunoassay) 10 tests/kit98/79 Monkeypox Virus Antigen Rapid Test Kit (Lateral Flow Immunoassay) 25 tests/kit98/79 Monkeypox Virus Antigen Rapid Test Kit (Lateral Flow Immunoassay) 40 tests/kit98/79 Monkeypox Virus Antigen Rapid Test Kit (Lateral Flow Immunoassay) 50 tests/kit98/79 Mycoplasma Pneumoniae Antigen Rapid Test Kit (Lateral Flow Immunoassay) 10 tests/kit98/79 Mycoplasma Pneumoniae Antigen Rapid Test Kit (Lateral Flow Immunoassay) 25 tests/kit98/79 Mycoplasma Pneumoniae Antigen Rapid Test Kit (Lateral Flow Immunoassay) 40 tests/kit98/79 Mycoplasma Pneumoniae Antigen Rapid Test Kit (Lateral Flow Immunoassay) 50 tests/kit98/79 Nipah Virus Nucleic Acid Amplification Test Kit (RT-qPCR) 24 tests/kit98/79 Nipah Virus Nucleic Acid Amplification Test Kit (RT-qPCR) 25 tests/kit98/79 Nipah Virus Nucleic Acid Amplification Test Kit (RT-qPCR) 48 tests/kit98/79 Nipah Virus Nucleic Acid Amplification Test Kit (RT-qPCR) 50 tests/kit98/79 Norovirus GI/II Antigen Rapid Test Kit (Lateral Flow Immunoassay) 10 tests/kit98/79 Norovirus GI/II Antigen Rapid Test Kit (Lateral Flow Immunoassay) 25 tests/kit98/79 Norovirus GI/II Antigen Rapid Test Kit (Lateral Flow Immunoassay) 40 tests/kit98/79 Norovirus GI/II Antigen Rapid Test Kit (Lateral Flow Immunoassay) 50 tests/kit98/79 Treponema Pallidum Antibody Rapid Test Kit (Lateral Flow Immunoassay) 10 tests/kit98/79 Treponema Pallidum Antibody Rapid Test Kit (Lateral Flow Immunoassay) 25 tests/kit98/79 Treponema Pallidum Antibody Rapid Test Kit (Lateral Flow Immunoassay) 40 tests/kit98/79 Treponema Pallidum Antibody Rapid Test Kit (Lateral Flow Immunoassay) 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	E. histolytica & Giardia lamblia & Crypto Combo Rapid Test Kit MI-F4300198/79 FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device MI-S4500198/79 Rotavirus-Adenovirus-Norovirus Combo test MI-F4300398/79 Rotavirus/Adenovirus/Norovirus/Astrovirus Combo Test MI-F4400198/79	– 98/79	Website contact@diareagent.com EUDAMED record Report an error
Euroimmun FDA	Germany	Anti-TBE Virus CSF ELISA 2.0 (IgG) EI 2661-2L G Anti-TBE Virus CSF ELISA 2.0 (IgM) EI 2661-2L M Anti-TBE Virus ELISA 2.0 (IgG) EI 2661-2 G Anti-TBE Virus ELISA 2.0 (IgM) EI 2661-2 M	B IVDR	Website info@euroimmun.de EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Adenovirus / RSV / Influenza A+B Combo Rapid Test IARI-53598/79 Adenovirus and RSV Combo Rapid Test Cassette(Nasopharyngeal Swab) IARC-52598/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test Cassette IARI-53598/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test Cassette with LF READER PLUS98/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Targetingone EU representative : SUNGO Europe B.V. (Netherlands)	China	JCV/BKV nucleic acid digital PCR detection kit JB01-Q2498/79 JCV/BKV nucleic acid digital PCR detection kit JB01-Y2498/79 Monkeypox virus nucleic acid real-time PCR detection kit MV01-1Y3298/79 Monkeypox virus nucleic acid real-time PCR detection kit MV02-Y3298/79	– 98/79	EUDAMED record Report an error
Capitalbiotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	32 tests/kit98/79 96 tests/kit98/79 96 tests/kit (A)98/79	– 98/79	EUDAMED record Report an error
Genesc EU representative : Lotus NL B.V. (Netherlands)	China	COVID-19 Nucleic Acid Rapid Test GE-RC43 refs98/79 Novel Coronavirus 2019-nCoV Rapid Detection Kit (LAMP) GE-RT962 refs98/79	– 98/79	info@genesc.cn EUDAMED record Report an error
Immundiagnostik FDA	Germany	MutaPLEX® FSME, PCR2 refs98/79 MutaPLEX® HSV/VZV, PCR2 refs98/79	– 98/79	Website info@immundiagnostik.com EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland)	Serbia	FSME/TBE IgG98/79 FSME/TBE IgM98/79	– 98/79	Website EUDAMED record Report an error
Triplex International Biosciences (China) EU representative : Lotus NL B.V. (Netherlands)	China	Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescent Probe)98/79 SARS-CoV-2 Antigen Rapid Test Kit3 refs98/79	– 98/79	Website info@tibchina.com EUDAMED record Report an error
Bio-Rad FDA	France	Platelia Rabies II	C IVDR	Website contact@bio-rad.com EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium)	South Korea	AFIAS Zika IgG/IgM98/79	– 98/79	Website marketing@boditech.co.kr 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
Genetic Analysis	Norway	GA-map® COVID-19 Fecal Test Kit98/79	– 98/79	Website info@genetic-analysis.com EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Card type, Card box type98/79	– 98/79	Website EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain)	China	MPxV Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79	– 98/79	EUDAMED record Report an error
Oslo universitetssykehus HF	Norway	Virus transportmedium	A IVDR	Website EUDAMED record Report an error
R-Biopharm FDA	Germany	RIDA®QUICK Rotavirus/Adenovirus Sample Diluent	A IVDR	Website EUDAMED record Report an error
Realytech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Human Monkeypox Virus (MPV) Real Time PCR Assay Kit MDK021415T98/79	– 98/79	Website info@realytech.com EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	Poliovirus type 1, type 2, and type 3 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Sendai Virus Real Time RT-PCR Kit98/79	– 98/79	Website EUDAMED record Report an error
Singclean EU representative : SUNGO Europe B.V. (Netherlands)	China	Singclean® COVID-19 & FLU A/B Antigen Test Kit (Colloidal Gold)2 refs98/79	– 98/79	Website EUDAMED record Report an error
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Detection Kit for 2019-nCOV,Influenza A Virus and Influenza B Virus（PCR Fluorescence Probe）98/79	– 98/79	sales@singuway.com EUDAMED record Report an error
Xpedite Diagnostics	Germany	SwiftX Virus2 refs	A IVDR	Website info@xpedite-dx.com EUDAMED record Report an error
Zetmedikal	Türkiye	SOFTEC Human Papillomavirus (HPV) High Risk Panel Qualitative RT-qPCR Detection Kit TUBE98/79	– 98/79	Website info@zetmedikal.com EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands)	China	Adenovirus/RSV Combo Rapid Test GIADR98/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Biotime EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	Virus RNA Collection Kit98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

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