Infectious diseasesMultiple parameters - (infect. immunology/NAT)Multiple viruses panels

Multiple viruses - multiplex assays - other

EMDN code W0105070399

40 manufacturers, 175 models including 169 on the market, 8 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 40

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	Adenovinus/RSV /influenza A+B Combo Rapid Test Cassette98/79 Adenovirus / RSV / Influenza A+B Combo Rapid Test Cassette IARI-R53598/79 Adenovirus and RSV Combo Rapid Test Cassette IARC-52598/79 Adenovirus, RSV and lnfluenza А+В Combo Rapid Test Cassette98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test98/79 15 others Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 COVID-19 Ag/Influenza A+B Combo Test Cassette(NP Swab)98/79 COVID-19 and Influenza A+B Antigen Combo Rapid Test98/79 COVID-19 Antigen/Influenza A+B Combo Test Cassette98/79 Multi-Respiratory Antigen Test (Nasopharyngeal Swab) IRTC-595(DSW)98/79 Multiplex Respiratory Antigen Rapid Test (Nasopharyngeal Swab) IRTC-565(DSW)98/79 Multiplex Respiratory Antigen Rapid Test (Nasopharyngeal Swab) IRTC-575(DSW)98/79 RSV/Influenza A+B Combo Rapid Test Cassette IRIC-52598/79 RSV/Influenza A+B Combo Rapid Test Cassette IRIC-R52598/79 RSV/Influenza A+B Test Cassette FI-RIV-50298/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test2 refs98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/InfluenzaA+B/RSV/Adenovirus/M. pneumoniae Antigen Combo Rapid Test98/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
AusDiagnostics EU representative : Advena Limited (Malta) and 1 other	Australia	RIDA®Plex Herpes, Enterovirus and Adenovirus 8 well Step 198/79 RIDA®Plex Herpes, Enterovirus and Adenovirus 8 well Step 298/79 RIDA®Plex Viral 12 well Step 198/79 RIDA®Plex Viral 12 well Step 298/79 RIDA®Plex Viral 8 well Step 198/79 12 others RIDA®Plex Viral 8 well Step 298/79 RIDA®Plex Viral and Syphilis 12 well Step 198/79 RIDA®Plex Viral and Syphilis 12 well Step 298/79 Step 1 tubes for Herpes, Enterovirus and Adenovirus 8-well98/79 Step 1 tubes for Viral 8-well98/79 Step 1 tubes for Viral CSF (8-well)98/79 Step 1 tubes for Viral Panel 12-well98/79 Step 2 Plates for Herpes, Enterovirus and Adenovirus 8-well98/79 Step 2 Plates for Viral 8-well98/79 Step 2 Plates for Viral CSF (8-well)98/79 Step 2 Plates for Viral Panel 12-well98/79 Viral and Syphilis 12-well2 refs98/79	– 98/79	Website regulatory@r-biopharm.com.au EUDAMED record Report an error
Ortho-Clinical Diagnostics Dba Quidel EU representative : MDSS GmbH (Germany)	United States	D3 Double Duet DFA Respiratory Virus Screening & ID Kit98/79 D3 Duet DFA Influenza A/Respiratory Virus Screening kit98/79 D3 Duet DFA RSV/Respiratory Virus Screening Kit98/79 D3 Respiratory Virus Antigen Control Slides98/79 D3 Ultra 8 DFA Respiratory Virus Screening & Identification Kit98/79 8 others D3 Ultra DFA Influenza A / Influenza B 10 mL Reagent Set98/79 D3 Ultra DFA Influenza A / Influenza B 2 mL Reagent Set98/79 D3 Ultra DFA Parainfluenza Reagent Set98/79 D3 Ultra DFA Respiratory Virus Direct Specimen Screening set98/79 D3 Ultra DFA Respiratory Virus ID Set98/79 D3 Ultra DFA Respiratory Virus Screening and Identification kit98/79 D3 Ultra DFA Respiratory Virus Shell Vial Screening Set98/79 D3 Ultra DFA RSV Reagent Set98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Medunion S.L. (Spain) and 1 other	China	CESONO：COVID-19 & Influenza A+B & RSV & ADV & HMPV Antigen Combo Test Kit (LFA) Cassette3 refs COVID-19 /Flu A /Flu B &RSV /ADV /HMPV Antigen ComboTest Kit (LFA） Cassette98/79 COVID-19& Influenza A+B & RSV Antigen Combo Test Kit (LFA) Cassette3 refs Eight Respiratory Pathogens Antigen Test Kit Cassette98/79 Eleven Respiratory Pathogens Antigen Test Kit Cassette2 refs98/79 6 others Influenza A+B & RSV Antigen Test Kit (Colloidal Gold) Cassette3 refs98/79 Nine Respiratory Pathogens Antigen Test Kit(LFA) Cassette3 refs98/79 SARS-CoV-2 & Influenza A+B & RSV & ADV & Mycoplasma Pneumoniae Antigen Combo Test Kit (Colloidal Gold) Cassette2 refs98/79 SARS-CoV-2 & Influenza A+B & RSV&ADV Antigen Combo Test Kit (Colloidal Gold) Cassette2 refs98/79 Ten Respiratory Pathogens Antigen Test Kit(LFA) Cassette2 refs98/79 Twelve Respiratory Pathogens Antigen Test Kit Cassette3 refs98/79	C IVDR, 98/79	sales@dbluemedical.com EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	Adenovirus & RSV Combo Rapid Test Device – Nasopharyngeal Swab D-ARD1098/79 Adenovirus Antigen Rapid Test Device – Swab D-ADAGD2098/79 Adenovirus antigen Test Device -Feces D-FIADED2598/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test Device - Nasopharyngeal Swab D-ARID1098/79 COVID-19 Antigen Rapid Test Device – Oral Fluid98/79 6 others COVID-19 IgG Rapid Test Device – WB/S/P98/79 COVID-19,Flu A+B &RSV Combo Rapid Test -Nasopharyngeal swab98/79 RSV & Influenza A+B Combo Rapid Test Device – Swab/Nasal D-RID1098/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test Device – Nasal Swab2 refs98/79 SARS-CoV-2 Antigen Rapid Test Device – Oral Fluid98/79 SARS-CoV-2 IgG/ IgM Rapid Test Device (WB/S/P)98/79	– 98/79	Website info@rapidlabs.co.uk EUDAMED record Report an error
Tigsun EU representative : CMC Medical Devices & Drugs SL (Spain)	China	1 test2 refs98/79 10 tests2 refs98/79 100 tests2 refs98/79 20 tests2 refs98/79 25 tests2 refs98/79 4 others 40 tests2 refs98/79 5 tests2 refs98/79 50 tests2 refs98/79 80 tests2 refs98/79	– 98/79	EUDAMED record Report an error
Vitrosens	Türkiye	RapidFor™ RapidFor™ SARS-CoV-2 + FLU A/B + hMPV + HPIV + RSV/ADV Test Kit RapidFor™ VMD149FD98/79 RapidFor™ VMD149SC98/79 RapidFor™ VMD153FD98/79 3 others RapidFor™ VMD93FD98/79 RapidFor™ VMD93TD98/79 RapidFor™ VMD96TD98/79	B IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany)	United States	Adenovirus and RSV Combo Rapid Test Cassette (Nasopharyngeal Swab) IARC-52598/79 Adenovirus,RSVand Influenza A+BCombo Rapid Test Cassette98/79 COVID-19 Antigen / Influenza A+B Combo Test Cassette (Nasopharyngeal Swab)98/79 RSV/ Influenza A+B Combo Rapid Test Cassette (Swab/ Nasal Aspirate)2 refs98/79 SARS-Co V-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test98/79 1 other SARS-Co V-2/Influenza A+B/RSVAntigen Combo Rapid Test98/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	Duplex Real-Time PCR Detection Kit for Coxsackievirus A16 and Human Enterovirus 712 refs98/79 Duplex Real-Time PCR Diagnostic Kit for Rapid Detection of Coxsackievirus A16 and Human Enterovirus 7198/79 Influenza A / B / Parainfluenza virus Antigen Rapid Test Cassette (Colloidal Gold Method)98/79 Real-time PCR Detection Kit for Coxsackievirus A16, Enterovirus 71 and Enterovirus98/79 Rotavirus/Adenovirus/Norovirus Antigen Rapid Test Cassette (Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
BeijingModern GaoDa Biotechnology EU representative : Medunion S.L. (Spain)	China	1 T/kit98/79 100T/kit98/79 15 T/kit98/79 40 T/kit98/79 5 T/kit98/79	– 98/79	EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	Flu A&B/RSV Ag Combo Rapid Test Cassette (Swab) GCFR-T502a98/79 Flu A/RSV Ag Combo Rapid Test Cassette (Swab) GCFR(A)-T502a98/79 Influenza A&B Ag Test Kit (Time-Resolved FIA) FCFLU(A/B)-502Fa98/79 RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab) FCRA-T502a98/79 SARS-CoV-2 + Flu A&B Ag Test Kit (Time-Resolved FIA) FCFC-T502a98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Gensurebio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	GenSure Rotavirus/Adenovirus/Norovirus Combo Rapid Test P240198/79 Rotavirus/Adenovirus Combo Rapid Test P202498/79 Rotavirus/Adenovirus/Norovirus Combo Rapid Test P240198/79 Rotavirus/Adenovirus/Norovirus/Astrovirus Combo Rapid Test P240398/79	– 98/79	Website info@gensurebio.com EUDAMED record Report an error
Molbio Diagnostics EU representative : QbD RepS BV (Belgium)	India	Truenat Dengue/Chikungunya 60104000598/79 Truenat Dengue/Chikungunya 60104002098/79 Truenat Dengue/Chikungunya 60104002598/79 Truenat Dengue/Chikungunya 60104005098/79	– 98/79	Website customersupport@molbiodiagnostics.com EUDAMED record Report an error
Thermofisher FDA EU representative : Life Technologies Europe B.V. (Netherlands)	United States	TaqPath™ 1-Step Multiplex Master Mix (no ROX)98/79 TaqPath™ COVID-19, Flu A/B, RSV Assay Kit98/79 TaqPath™ COVID-19, Flu A/B, RSV Control98/79 TaqPath™ COVID-19, Flu A/B, RSV Control Dilution Buffer98/79	– 98/79	EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain)	China	SARS-CoV-2 & Influenza A/B & RSV & ADV Antigen Combo Rapid Test Kit(Lateral Chromatography) 1 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV & ADV Antigen Combo Rapid Test Kit(Lateral Chromatography) 25 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV & ADV Antigen Combo Rapid Test Kit(Lateral Chromatography) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Diagreat EU representative : Medunion S.L. (Spain)	China	2019-nCoV and Influenza A/B Combo Antigen Test Kit 25 tests/box 2019-nCoV/Influenza A+B/RSV Antigen Combo Rapid Test Kit 25 tests/box Influenza A/B Antigen Determination Kit (Fluorescence Immunochromatographic Assay) 25 tests/box	B IVDR	Website info@diagreat.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	Influenza A&B Ag Test Kit (Time-Resolved FIA) FCFLU(A/B)-502Fa98/79 RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab) FCRA-T502a98/79 SARS-CoV-2 + Flu A&B Ag Test Kit (Time-Resolved FIA) FCFC-T502a98/79	– 98/79	EUDAMED record Report an error
Rocgene FDA EU representative : Medunion S.L. (Spain)	China	10 tests/kit3 refs98/79 50 tests/kit2 refs98/79 60 tests/kit98/79	– 98/79	sale@rocgene.com EUDAMED record Report an error
Sansure FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Astrovirus/Sapovirus/Enteric Adenovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)4 refs98/79 SARS-CoV-2/InFluA/InFluB Rapid Antigen Test (Immunochromatography Assay)98/79	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Shenzhen Kang Sheng Bao Bio-Technology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	InfectCheck SARS-CoV-2/RSV/FluA/FluB SARS-CoV-2/RSV/ FluA/ FluB Antigen Rapid Test98/79 SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)98/79 SARS-CoV-2/InFluA/InFluB Antigen Rapid Test (Colloidal Gold)98/79	– 98/79	Website info@ksbbiotech.com EUDAMED record Report an error
Synthgene (Yixing) Health Technology EU representative : MedPath GmbH (Germany)	China	COVID-19/Influenza A+B Antigen Combo Rapid Test Kit(Colloidal gold method)98/79 COVID-19/Influenza(A+B)/RSV Antigen Combo Rapid Test Kit(Colloidal gold method)98/79 SARS-COV-2 Nucleocapsid(N) Antigen Rapid Detection kit (Colloidal gold method))98/79	– 98/79	sales@syngenebio.com EUDAMED record Report an error
Acesolab FDA EU representative : VidaQuick Biotech S.L. (Spain)	United States	Multi-Respiratory Antigen Test (Swab) SWx5-RTC(PLUS)98/79 Multi-Respiratory Antigen test (Swab) SWx5-RTC(PRO)98/79	– 98/79	info@acesolab.com EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi	Türkiye	Enteric Viral Panel Detection and Monitoring Kit (24)3 refs98/79 Enteric Viral Panel Detection and Monitoring Kit (48)3 refs98/79	– 98/79	Website EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium)	South Korea	AFIAS Rota/Adeno98/79 ichroma™ Influenza A+B/RSV98/79	– 98/79	Website marketing@boditech.co.kr EUDAMED record Report an error
Idilbiotech	Türkiye	RevoDx Candida spp qPCR Kit98/79 RevoDx HBV/HCV Qualitative qPCR Kit3 refs98/79	– 98/79	Website EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Dengue Virus, Zika Virus and Chikungunya Virus Multiplex Nucleic Acid Detection Kit (Fluorescence PCR)98/79 Influenza A/B Antigen Detection Kit (Immunochromatography)98/79	– 98/79	marketing@hongweitest.com EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Coxsackie virus group A type 16 & enterovirus type 71 Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Flu AB + SARS-CoV-2 Antigen Rapid Detection Kit(Colloidal Gold) 25 Tests/kit98/79	– 98/79	Website sales@szzijian.com EUDAMED record Report an error
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Combined Diagnostic Kit for Adenovirus Antigen and Rotavirus Antigen (Immunochromatographic Assay)98/79 Enterovirus 71/Coxsackievirus A16 IgM Antibody Test98/79	– 98/79	Website sales@wondfo.com.cn EUDAMED record Report an error
Abiores Technology (Beijing) EU representative : Sungo Cert GmbH (Germany)	China	Rotavirus/Adenovirus Combo Test Cassette AH50-2098/79	– 98/79	EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic	Türkiye	Anatolia Geneworks3 refs	C IVDR	Website info@anatoliagenetik.com EUDAMED record Report an error
Ecolidx	Czechia	eSens JCV/BKV QT PCR kit98/79	– 98/79	Website 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
KH Medical EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	RADI FAST Flu-SC2 Detection Kit98/79	– 98/79	Website info@khmedical.co.kr EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain)	China	SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79	– 98/79	EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	STANDARD™ F S. pneumo & Legio Combo Ag FIA F-PNLG-01C	C IVDR	Website EUDAMED record Report an error
Viuick EU representative : SUNGO Europe B.V. (Netherlands)	China	VIUICK98/79	– 98/79	EUDAMED record Report an error
Zetmedikal	Türkiye	SOFTEC SARS-CoV-2 Antigen Rapid Test Kit (Nasal Swab) SFSCAGN198/79	– 98/79	Website info@zetmedikal.com EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	China	24 tests/kit2 refs98/79 (no longer marketed) 48 tests/kit2 refs98/79 (no longer marketed) 96 tests/kit2 refs98/79 (no longer marketed) AP1：24 tests/kit98/79 (no longer marketed) AP1：48 tests/kit98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Fluxergy FDA EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	United States	Fluxergy HVRe Influenza/RSV/ SARS-CoV-22 refs98/79 (no longer marketed)	– 98/79	Website info@fluxergy.com 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) 8

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
DIAGNOSTIC HYBRIDS, INC.	United States	D3 Ultra D3 Fastpoint D3 D3 Duet	K092882 (2009)
DRG Instruments Gesellschaft mit beschränkter Haftung	–	Influenza Virus B IgG ELISA Influenza Virus A IgG ELISA	registered
DRG International Inc	United States	Influenza Virus B IgG ELISA Influenza Virus A IgG ELISA	registered
Gold Standard Diagnostics Frankfurt GmbH Present in Europe in other categories	–	NovaLisa Influenza Virus B IgG NovaLisa Influenza Virus A IgG	registered
Oxoid U.S.A., Inc. Present in Europe in other categories	United States	IMAGEN Respiratory Screen Kit IMAGEN RESPIRATORY SCREEN POS CON SLIDE	registered
BIOCHECK, INC.	United States	–	registered
Diagnostic Automation /Cortez Diagnostics Inc.	United States	–	registered
QuidelOrtho Corporation	United States	–	registered

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