Infectious diseasesOther virology tests (infect. immunology/NAT)Other virology antigen/antibody detection

Hantavirus / bunyavirus

EMDN code W0105040614

11 manufacturers, 42 models including 42 on the market, 5 countries

On the market in Manufacturer country

Manufacturers registered in Europe (EUDAMED) 11

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
Euroimmun FDA	Germany	Anti-Hanta Virus Pool 1 "Eurasia" ELISA (IgG) EI 278h-1 G98/79 Anti-Hanta Virus Pool 1 "Eurasia" ELISA (IgM) EI 278h-1 M98/79 Anti-Hanta Virus Pool 2 "America" ELISA (IgG) EI 278h-2 G98/79 Anti-Hanta Virus Pool 2 "America" ELISA (IgM) EI 278h-2 M98/79 IIFT: Hantavirus Mosaic 1 (IgG) FI 278h-1 G2 refs98/79 13 others IIFT: Hantavirus Mosaic 1 (IgM) FI 278h-1 M2 refs98/79 IIFT: Hantavirus Mosaic 1 EUROPattern (IgG) FR 278h-1 G98/79 IIFT: Hantavirus Mosaic 1 EUROPattern (IgM) FR 278h-1 M98/79 IIFT: Hantavirus Mosaic 2: Eurasia (IgG) FI 278h-2 G2 refs98/79 IIFT: Hantavirus Mosaic 2: Eurasia (IgM) FI 278h-2 M2 refs98/79 IIFT: Hantavirus Mosaic 3: America (IgG) FI 278m-3 G98/79 IIFT: Hantavirus Mosaic 3: America (IgM) FI 278m-3 M98/79 IIFT: Hantavirus Mosaic 3: America EUROPattern (IgG) FR 278m-3 G98/79 IIFT: Hantavirus Mosaic 3: America EUROPattern (IgM) FR 278m-3 M98/79 IIFT: Sandfly fever virus Mosaic 1 (IgG) FI 277a-1 G3 refs98/79 IIFT: Sandfly fever virus Mosaic 1 (IgM) FI 277a-1 M2 refs98/79 IIFT: Sandfly fever virus Mosaic 1 EUROPattern (IgG) FR 277a-1 G98/79 IIFT: Sandfly fever virus Mosaic 1 EUROPattern (IgM) FR 277a-1 M98/79	– 98/79	Website info@euroimmun.de EUDAMED record Report an error
Abbott FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Bioline™ Hantaanvirus 17FK1098/79 Bioline™ Hantaanvirus 17FK1198/79 SD BIOLINE Hantaan virus 17FK1098/79 SD BIOLINE Hantaan virus 17FK1198/79 SD BIOLINE Malaria Ag P.f/P.v 05FK8698/79	– 98/79	Website EUDAMED record Report an error
Gold Standard Diagnostics FDA	Germany	Hantavirus IgG98/79 Hantavirus IgM98/79 NovaLisa® Hantavirus IgG98/79 NovaLisa® Hantavirus IgM98/79	– 98/79	info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Reagena	Finland	Reageana DOBRAVA-HANTAAN IgG EIA98/79 Reagena DOBRAVA-HANTAAN IgM EIA98/79 Reagena PUUMALA IgG EIA98/79 Reagena PUUMALA IgM EIA98/79	– 98/79	Website info@reagena.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	Hantavirus IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHV(IgG/IgM)-402a98/79 Hantavirus IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHV(IgM)-402a98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Mikrogen	Germany	recomLine HantaPlus IgG98/79 recomLine HantaPlus IgM98/79	– 98/79	EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Hantavirus IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHV(IgG/IgM)-402a98/79 Hantavirus IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHV(IgM)-402a98/79	– 98/79	EUDAMED record Report an error
Zhongshan Bio-Tech EU representative : Lotus NL B.V. (Netherlands)	China	25 tests/kit98/79 96 tests/kit2 refs98/79	– 98/79	EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany)	United States	Hantavirus IgG/IgM Rapid Test Cassette (Whole Blood/ Serum/ Plasma) IHVGM-ACO40298/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Hantavirus lgG/lgM Rapid Test Cassette98/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Hantavirus Renal Syndrome Type II Real Time RT-PCR Kit98/79	– 98/79	Website EUDAMED record Report an error

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