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

Zika virus

EMDN code W0105040630

28 manufacturers, 81 models including 79 on the market, 10 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 28

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
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Zika antigen Test Cassette FI-ZI-40298/79 Zika IgG/IgM and NS1 Combo Rapid Test Cassette2 refs98/79 Zika IgG/IgM and NS1 Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Zika IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) IZIB-40298/79 Zika IgG/IgM Rapid Test Cassette IZIB-40298/79 4 others Zika IgG/IgM Rapid Test Cassette IZIB-R40298/79 Zika IgM Test Cassette FI-ZIM-40298/79 Zika NS1 Rapid Test Cassette2 refs98/79 Zika NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Euroimmun FDA	Germany	Anti-Zika Virus ELISA (IgAM) EI 2668 Q98/79 Anti-Zika Virus ELISA (IgG) EI 2668 G98/79 Anti-Zika Virus ELISA (IgM) EI 2668 M98/79 Anti-Zika virus IIFT (IgG) FI 2668 G2 refs98/79 Anti-Zika virus IIFT (IgM) FI 2668 M2 refs98/79 2 others Anti-Zika virus IIFT EUROPattern (IgG) FR 2668 G2 refs98/79 Anti-Zika virus IIFT EUROPattern (IgM) FR 2668 M2 refs98/79	– 98/79	Website info@euroimmun.de EUDAMED record Report an error
Vitrosens	Türkiye	ChainFor™3 refs ChainFor™ CFP73P10098/79 ChainFor™ CFP73P2598/79 LyoSens™ LYO73WS9698/79 RapidFor™ 2 others RapidFor™ Zika IgG/IgM Rapid Test Kit (FIA) VMPO7698/79 RapidFor™ Zika IgM Rapid Test Kit VMD4398/79	C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	United States	Zika antigen Test Cassette (Whole Blood/ Serum/ Plasma) ACO-ZI-40298/79 Zika IgG/IgM and NS1 Combo Rapid Test Cassette98/79 Zika IgG/IgM and NS1 Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Zika IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) IZIB-40298/79 Zika IgM Test Cassette (Whole Blood/ Serum/ Plasma) ACO-ZIM-40298/79 1 other Zika NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Gold Standard Diagnostics FDA	Germany	NovaLisa® Zika Virus IgG capture2 refs98/79 NovaLisa® Zika Virus IgM μ-capture2 refs98/79 Zika Virus IgG capture ELISA98/79 Zika Virus IgM μ-capture98/79 Zika Virus IgM μ-capture ELISA98/79	– 98/79	info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	Zika antigen Test Device -WB/S/P98/79 Zika IgG/IgM & NS1 Combo Rapid Test Device – WB/S/P98/79 Zika IgG/IgM Rapid Test Device – WB/S/P98/79 Zika IgM Test Device -WB/S/P98/79 Zika NS1 Rapid Test Device -WB/S/P98/79	– 98/79	Website info@rapidlabs.co.uk EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland)	Serbia	Zika Virus IgG N151D24ZVG98/79 Zika Virus IgG U151D98/79 Zika Virus IgM N150D24ZVM98/79 Zika Virus IgM U150D98/79	– 98/79	Website EUDAMED record Report an error
Vircell	Spain	ZIKA ELISA IgG G102398/79 ZIKA ELISA IgM M102398/79 ZIKA VIRCLIA® IgG MONOTEST VCM033 ZIKA VIRCLIA® IgM MONOTEST VCM03598/79	C IVDR, 98/79	EUDAMED record Report an error
Abbott FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Bioline™ Zika IgM 12FK2198/79 Bioline™ Zika IgM 12FK2698/79 SD BIOLINE Zika IgM 12FK2698/79 SD BIOLINE Zika IgM98/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error
Hangzhou Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Zika Virus IgG/IgM And NS1 Combo Test98/79 Zika virus IgG/IgM Rapid Test :HZIK009T98/79 Zika virus NS1 Antigen Rapid Test98/79	– 98/79	info@jgbiotech.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	Zika IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) GCZIK(IgG)-402b98/79 Zika IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma) GCZIK(IgG/IgM)-T402a98/79 Zika NS1 Ag Rapid Test Cassette(Whole blood/Serum/Plasma) GCZIK(NS1)-402a98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Zika IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) GCZIK(IgG)-402b98/79 Zika IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma) GCZIK(IgG/IgM)-T402a98/79 Zika NS1 Ag Rapid Test Cassette(Whole blood/Serum/Plasma) GCZIK(NS1)-402a98/79	– 98/79	EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands)	China	Zika IgG/IgM Rapid Test GIZGM98/79 Zika IgG/IgM/NS1 Combo Rapid Test GIZGMN98/79 Zika NS1 Rapid Test GIZNS198/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Zika IgG/IgM Rapid Test 1Test/Kit98/79 Zika IgG/IgM Rapid Test 25Tests/Kit98/79	– 98/79	Website EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany)	China	Zika IgG/IgM Rapid Test ZIKA-422a98/79 Zika NS1 Rapid Test98/79	– 98/79	Website EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	QINGLI Device:20 Test/Kit2 refs98/79 QINGLI Strip: 25Tests/Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Abiores Technology (Beijing) EU representative : Sungo Cert GmbH (Germany)	China	ZiKA IgG/IgM Test Strip & Cassette AB220-2098/79	– 98/79	EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Medunion S.L. (Spain)	China	Zika IgG/IgM Antibody Test Kit (Colloidal Gold） Cassette98/79	– 98/79	sales@dbluemedical.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	Zika IgG/IgM Rapid Test ZIKA-W23M98/79	– 98/79	Website contact@diareagent.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	Zika Virus NS1 Antigen Rapid Test Cassette (Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands)	China	Rapid Zika Virus IgG/IgM Combo Test Card 1N28C298/79	– 98/79	Website EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany)	China	Zika Virus IgG/IgM Antibody Rapid Test Kit GKPD12098/79	– 98/79	office@guoke-medical.com EUDAMED record Report an error
Diapro	Italy	ZIKV IgM ZIKVM.CE98/79	– 98/79	Website info@diapro.it 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
HangZhou Biotest Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Rightsign IZGM-C4298/79	– 98/79	info@biotests.com.cn EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Canada	Zika NS1 Ag Rapid Test Cassette (Whole blood/Serum/Plasma) GCZIK(NS1)-402a98/79	– 98/79	sales@orientgene.com EUDAMED record Report an error
Mpbio FDA	Germany	Rapid Zika Virus IgG/IgM Combo Test Card2 refs98/79	– 98/79	Website EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	Zika Rapid Test98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

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