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

Influenza & para influenza

EMDN code W0105040604

42 manufacturers, 149 models including 146 on the market, 12 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 42

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
TestLine Clinical Diagnostics s.r.o	Czechia	EIA Influenza A IgA98/79 EIA Influenza A IgG98/79 EIA Influenza A IgM98/79 EIA Influenza B IgA98/79 EIA Influenza B IgG98/79 13 others EIA Influenza B IgM98/79 EIA Parainfluenza mix IgA98/79 EIA Parainfluenza mix IgG98/79 EIA Parainfluenza mix IgM98/79 SmartEIA Influenza A IgA98/79 SmartEIA Influenza A IgG98/79 SmartEIA Influenza A IgM98/79 SmartEIA Influenza B IgA98/79 SmartEIA Influenza B IgG98/79 SmartEIA Influenza B IgM98/79 SmartEIA Parainfluenza mix IgA98/79 SmartEIA Parainfluenza mix IgG98/79 SmartEIA Parainfluenza mix IgM98/79	– 98/79	Website info@testlinecd.com EUDAMED record Report an error
Gold Standard Diagnostics FDA	Germany	Influenza Virus A IgA98/79 Influenza Virus A IgG98/79 Influenza Virus A IgM98/79 Influenza Virus B IgA98/79 Influenza Virus B IgG98/79 11 others Influenza Virus B IgM98/79 NovaLisa® Influenza Virus A IgA2 refs98/79 NovaLisa® Influenza Virus A IgG2 refs98/79 NovaLisa® Influenza Virus A IgM2 refs98/79 NovaLisa® Influenza Virus B IgA2 refs98/79 NovaLisa® Influenza Virus B IgG2 refs98/79 NovaLisa® Influenza Virus B IgM2 refs98/79 NovaLisa® Parainfluenza Virus 1, 2, 3 IgA2 refs98/79 NovaLisa® Parainfluenza Virus 1, 2, 3 IgG2 refs98/79 Parainfluenza Virus 1, 2, 3 IgA98/79 Parainfluenza Virus 1, 2, 3 IgG98/79	– 98/79	info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Flu A&B/ Covid-19/ RSV/ Adenovirus /MP Antigen Rapid Test Panel 20Tests/Kit98/79 HPIVS Rapid Test 25Tests/Kit98/79 Inﬂuenza A Antigen Rapid Test 1Test/Kit98/79 Inﬂuenza A Antigen Rapid Test 20 Tests/Kit98/79 Inﬂuenza A Antigen Rapid Test 25Tests/Kit98/79 10 others Inﬂuenza A+B Antigen Rapid Test Device 1Test/Kit98/79 Inﬂuenza A+B Antigen Rapid Test Device 20Tests/Kit98/79 Inﬂuenza A+B Antigen Rapid Test Device 25Tests/Kit98/79 Inﬂuenza B Antigen Rapid Test 1Test/Kit98/79 Inﬂuenza B Antigen Rapid Test 20Tests/Kit98/79 Inﬂuenza B Antigen Rapid Test 25Tests/Kit98/79 SARS-CoV-2 & Inﬂuenza A/B Antigen Combo Rapid Test98/79 SARS-COV-2 Antigen Rapid Test Device 1Test/Kit98/79 SARS-COV-2 Antigen Rapid Test Device 20Tests/Kit98/79 SARS-COV-2 Antigen Rapid Test Device 5Tests/Kit98/79	– 98/79	Website EUDAMED record Report an error
Vircell	Spain	INFLUENZA A ELISA IgG/IgM G/M100798/79 INFLUENZA A VIRCLIA® IgG MONOTEST VCM04298/79 INFLUENZA B ELISA IgG/IgM G/M100898/79 INFLUENZA B VIRCLIA® IgG MONOTEST VCM04598/79 PARAINFLUENZA 1 ELISA IgG/IgM G/M100998/79 5 others PARAINFLUENZA 1 VIRCLIA® IgG MONOTEST VCM06598/79 PARAINFLUENZA 2 ELISA IgG/IgM G/M101098/79 PARAINFLUENZA 2 VIRCLIA® IgG MONOTEST VCM06898/79 PARAINFLUENZA 3 ELISA IgG/IgM G/M101198/79 PARAINFLUENZA 3 VIRCLIA® IgG MONOTEST VCM07198/79	– 98/79	EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland)	Serbia	Influenza A IgA N103V24IGA98/79 Influenza A IgG N104V24IGG98/79 Influenza A IgM N105V24IGM98/79 Influenza B IgA N106V24IGA98/79 Influenza B IgG N107V24IGG98/79 3 others Influenza B IgM N108V24IGM98/79 Parainfluenza IgG98/79 Parainfluenza IgM98/79	– 98/79	Website EUDAMED record Report an error
Arcdia	Finland	mariPOC® Influenza A virus test reagent98/79 mariPOC® Influenza B virus test reagent98/79 mariPOC® Parainfluenza virus 1 test reagent98/79 mariPOC® Parainfluenza virus 2 test reagent98/79 mariPOC® Parainfluenza virus 3 test reagent98/79	– 98/79	Website office@arcdia.com EUDAMED record Report an error
Euroimmun FDA	Germany	Anti-Influenza A Virus ELISA (IgA) EI 2691 A98/79 Anti-Influenza A Virus ELISA (IgG) EI 2691 G98/79 Anti-Influenza B Virus ELISA (IgA) EI 2692 A98/79 Anti-Influenza B Virus ELISA (IgG) EI 2692 G98/79 Anti-Parainfluenza Viruses Pool ELISA (IgG) EI 2721-1 G98/79	– 98/79	Website info@euroimmun.de EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	FLU A+B Test Cassette(Swab)98/79 H1N1 Antigen Rapid Test Cassette2 refs98/79 H1N1 Antigen Rapid Test Dipstick98/79 HPIV Rapid Test98/79 Influenza A+B Test Cassette FI-FLU-50298/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Vitrosens	Türkiye	RapidFor™ RapidFor™ VMD151FD98/79 RapidFor™ VMD151SC98/79 RapidFor™ VMD151SC0198/79 RapidFor™ VMPO123SC98/79	B IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Diesse FDA	Italy	CHORUS INFLUENZA A IgA CHORUSIAA2 refs CHORUS INFLUENZA A IgG CHORUSIAG2 refs CHORUS INFLUENZA B IgA CHORUSIBA2 refs CHORUS INFLUENZA B IgG CHORUSIBG2 refs	C IVDR	Website EUDAMED record Report an error
Dynamiker EU representative : Lotus NL B.V. (Netherlands)	China	100 tests4 refs98/79 200 tests4 refs98/79 24 tests/kit2 refs98/79 48 tests/kit2 refs98/79	– 98/79	Website marketing@dynamiker.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	APA01-AHG48E; APA01-AHG96E; APA01D-AHG48E; APA01D-AHG96E98/79 Flu A Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA) FCFLU(A)-502a98/79 Flu A(H5) Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA) FCFLU(AH5)-502a98/79 HPIV Antigen Rapid Test Kit (Time-Resolved FIA) FCHPIV-502a98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany)	United States	H1N1 Antigen Rapid Test Cassette (Swab)98/79 H1N1 Antigen Rapid Test Dipstick (Swab)98/79 Influenza A+B Test Cassette (Swab/ Nasal Aspirate)98/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium)	South Korea	AFIAS Flu A+B98/79 EZ POC Influenza A+B98/79 ichroma™ Influenza A+B98/79	– 98/79	Website marketing@boditech.co.kr EUDAMED record Report an error
NanoEntek FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	BioTracer™ Influenza A&B Rapid Card98/79 BioTracer™ Influenza A&B Test98/79 FREND FLU A&B98/79	– 98/79	Website eudamed@nanoentek.com EUDAMED record Report an error
Ningbo BESTest Bio-technology EU representative : SUNGO Europe B.V. (Netherlands)	China	1 test/kit98/79 25 tests/kit98/79 5 tests/kit98/79	– 98/79	EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Flu A Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA) FCFLU(A)-502a98/79 Flu A(H5) Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA) FCFLU(AH5)-502a98/79 HPIV Antigen Rapid Test Kit (Time-Resolved FIA) FCHPIV-502a98/79	– 98/79	EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	MAGLUMI Human Parainfluenza Virus IgM (CLIA)3 refs MAGLUMI Influenza A Virus IgM (CLIA)3 refs MAGLUMI Influenza B Virus IgM (CLIA)3 refs	B IVDR	Website EUDAMED record Report an error
Vellap	Germany	Cleartest Influenza A+B98/79 IDEAL Influenza A+B98/79 VELLAP Influenza A/B98/79	– 98/79	info@vellap.de EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Influenza A/B Antigen Fast Test Kit (Immunofluorescence Assay)7 refs98/79 Influenza A/B Rapid Test CG2059	B IVDR, 98/79	EUDAMED record Report an error
Hangzhou Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Influenza A Antigen Rapid Test HFLU015GA98/79 Influenza A+B Antigen Combo Test HFLU014GAB98/79	– 98/79	info@jgbiotech.com EUDAMED record Report an error
Oxoid FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	IMAGEN Influenza Virus A and B98/79 IMAGEN Parainfluenza Virus Types 1, 2 and 32 refs98/79	– 98/79	Website EUDAMED record Report an error
Remel FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)	United States	XPECT FLU A&B CONTROL 20SWAB/SET KT/2SET98/79 XPECT FLU A&B TEST KIT98/79	– 98/79	Website EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	SARS-CoV-2 Neutralizing Antibodies Test (Colloidal Gold)98/79 SARS-CoV-2 S-RBD Antibodies Test (Colloidal Gold)98/79	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Anhui Formaster Biosci EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Influenza A&B Rapid Test IIN-102398/79	– 98/79	Website EUDAMED record Report an error
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Flu A/B Ag Combo Test98/79	– 98/79	EUDAMED record Report an error
Beijing Lepu Medical Technology EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)	China	SARS-COV-2 Antigen Rapid Tests for Self-Testing CG361098/79	– 98/79	EUDAMED record Report an error
Beijing Zhongjian Antai Diagnostic Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Mycoplasma Pneumoniae Antigen Combo Test Cassette: 1 Test/Kit	B IVDR	EUDAMED record Report an error
Campmedica	Romania	See Now98/79	– 98/79	Website EUDAMED record Report an error
Diagreat EU representative : MedNet EC-REP GmbH (Germany)	China	Influenza A/B Antigen Rapid Test Kit 25 tests/box	B IVDR	Website info@diagreat.com EUDAMED record Report an error
Fanttest EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	1 test/kit98/79	– 98/79	info@fanttest.com EUDAMED record Report an error
Hangzhou Testsea Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Influenza Ag A/B Test RB00798/79	– 98/79	EUDAMED record Report an error
Hightopbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Card type98/79	– 98/79	Website EUDAMED record Report an error
Immundiagnostik FDA	Germany	PreventID® Influenza A+B98/79	– 98/79	Website info@immundiagnostik.com EUDAMED record Report an error
Isiabio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Influenza A/B (Flu A/B) virus antigen Rapid Test Kit (QDs Immunofluorescence Method) Flu A/B-QD98/79	– 98/79	Website EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany)	China	Parainfluenza(hPIV) Antigen Rapid Test98/79	– 98/79	Website EUDAMED record Report an error
Ortho-Clinical Diagnostics Summers Ridge San Diego EU representative : MDSS GmbH (Germany)	United States	Sofia Influenza A+B FIA2 refs98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
Realytech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Influenza A&B Rapid Test K251316T98/79	– 98/79	Website info@realytech.com EUDAMED record Report an error
Viuick EU representative : SUNGO Europe B.V. (Netherlands)	China	VIUICK98/79	– 98/79	EUDAMED record Report an error
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	One Step Influenza A&B Test5 refs98/79	– 98/79	Website sales@wondfo.com.cn EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	China	Influenza A+B/RSV Ag Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed) Influenza A+B/RSV Ag Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Biotime EU representative : Medunion S.L. (Spain) No model still on the market	China	BIOTIME3 refs98/79 (no longer marketed)	– 98/79	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.

Other manufacturers known in the United States (FDA) 14

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
Princeton BioMeditech Corp. Present in Europe in other categories	United States	BioSign Flu A+B card Status Flu A+B card Status Flu A+B Validation Kit Status Flu A & B Status Flu A+B Nasal Wash/Aspirate Kit	registered
Quidel Corp.	United States	QuickVue Sofia	K131606 (2013)
Becton, Dickinson & CO Present in Europe in other categories	United States	BD Veritor™ System Laboratory Combo Pack BD Veritor™ Plus CLIA-Waived Combo Pack	registered
MCKESSON MEDICAL-SURGICAL INC.	–	McKesson	registered
Polymedco, Inc.	United States	Poly stat	registered
Zhengzhou Shiyi Biotech Co., Ltd.	–	–	registered
BTNX Inc	–	Rapid Response	registered
HENRY SCHEIN, INC. Present in Europe in other categories	United States	Henry Schein	registered
LONGEVITI NEURO SOLUTIONS LLC	–	Longeviti Convenience Kit 5.0	registered
Sekisui Diagnostics, LLC Present in Europe in other categories	United States	OSOM Ultra Flu A&B Controls 5 Test	K123182 (2012)
Hangzhou Rollmed Co.,Ltd.	China	–	registered
STS Corporation	United States	–	registered
Sanicure BV	Netherlands	–	registered
Scantibodies Laboratory Inc.	United States	–	registered

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