Infectious diseasesOther virology tests (infect. immunology/NAT)Other virology - NA reagents

Influenza & para influenza - NA reagents

EMDN code W0105040504

46 manufacturers, 135 models including 129 on the market, 15 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 46

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
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	H1N1 TESPİT KİTİ H1N1 DETECTION KIT INF A/H1 TESPİT KİTİ INF A/H1 DETECTION KIT INF A/H1-2009 TESPİT KİTİ INF A/H1-2009 DETECTION KIT INF A/H3 TESPİT KİTİ INF A/H3 DETECTION KIT İNFLUENZA A-H5N1 TESPİT KİTİ INFLUENZA A- H5N1 DETECTION KIT 7 others İNFLUENZA -A,B TESPİT KİTİ İNFLUENZA -B TESPİT KİTİ İNFLUENZA A-B-C TARAMA KİTİ İNFLUENZA H5N2 TESPİT KİTİ INFLUENZA H5N2 DETECTION KIT İNFLUENZA TİPLEME KİTİ İNFLUENZA-A TESPİT KİTİ PARAİNFLUENZA (1, 2, 3, 4) TESPİT KİTİ PARAINFLUENZA (1, 2, 3, 4) DETECTION KIT	B, C IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Vitrosens	Türkiye	ChainFor Influenza A/B Detection qPCR Kit CFP6498/79 ChainFor Influenza ID-2 Genotyping Detection qPCR Kit CFP6798/79 ChainFor Influenza ID-3 Genotyping Detection qPCR Kit CFP6698/79 ChainFor™ Influenza A ID-4 Genotyping Detection qPCR Kit CFP6598/79 LyoSens FLU A qPCR Kit LYO146WS9698/79 6 others LyoSens FLU B qPCR Kit LYO147WS9698/79 LyoSens FLU A + B qPCR Kit LYO37WS9698/79 LyoSens H1N1 Detection qPCR Kit LYO3398/79 LyoSens Influenza A ID-4 Genotyping qPCR Kit LYO3898/79 LyoSens Influenza ID-2 Genotyping qPCR Kit LYO4098/79 LyoSens Influenza ID-3 Genotyping qPCR Kit LYO3998/79	– 98/79	Website info@vitrosens.com EUDAMED record Report an error
Poly Diagnostics	Luxembourg	Poly Diagnostics Influenza A, Influenza B, Influenza C, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza A, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza B, RNase P Real-Time PCR kit3 refs Poly Diagnostics Influenza typing II Real-Time PCR kit3 refs Poly Diagnostics Influenza typing Real-Time PCR kit3 refs 2 others Poly Diagnostics Parainfluenza viruses 1, 2, 3, 4 Real-Time PCR kit3 refs Poly Diagnostics Parainfluenza viruses 1, 2, 3/4, RNase P Real-Time PCR kit3 refs	B IVDR	Website info@polydiagnostics.com EUDAMED record Report an error
TIB MOLBIOL Syntheselabor	Germany	ModularDx Kit Influenza A98/79 ModularDx Kit Influenza A H1 (H1N1 sw) LightMix® Modular Influenza A H1(H1N1 sw)98/79 ModularDx Kit Influenza B98/79 ModularDx Kit Parainfluenza 1 LightMix® Modular Parainfluenza 198/79 ModularDx Kit Parainfluenza 2 LightMix® Modular Parainfluenza 298/79 2 others ModularDx Kit Parainfluenza 3 LightMix® Modular Parainfluenza 398/79 ModularDx Kit Parainfluenza 4 LightMix® Modular Parainfluenza 498/79	– 98/79	Website EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	Diagnostic Kit for Influenza A (H1N1) Virus（PCR-Fluorescence Probing）2 refs98/79 Influenza A and BV/BY RNA Diagnositc Kit（PCR-Fluorescence Probing）2 refs98/79 Influenza A Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Influenza A/B Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 Influenza BV/BY RNA Diagnostic Kit（PCR-Fluorescence Probing）2 refs98/79 2 others Parainfluenza Virus type 1, 2 and 3 Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)3 refs98/79 Influenza B Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)98/79 (no longer marketed)	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Idilbiotech	Türkiye	RevoDx Influenza A H1N1 (pdm09) qPCR Kit2 refs98/79 RevoDx Influenza A-H3 qPCR Kit2 refs98/79 RevoDx Parainfluenza virus 1 qPCR Kit2 refs98/79 RevoDx Parainfluenza virus 2 qPCR Kit2 refs98/79 RevoDx Parainfluenza virus 3 qPCR Kit2 refs98/79 1 other RevoDx Parainfluenza virus 4 qPCR Kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Suzhou TianLong Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Human Influenza Virus A/B & Respiratory Syncytial Virus Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Human Influenza Virus B (Yamagata&Victoria) and A (H1&H3) Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)98/79 Human Influenza Virus B Genotyping (Yamagata&Victoria) Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Influenza A/B Virus RNA Detection Kit (Fluorescence PCR Method)98/79 Influenza A/Influenza B/Respiratory Syncytial Virus (RSV) Nucleic Acid Detection Kit (Fluorescence PCR Method-0.1mL Pre-filled)98/79	– 98/79	EUDAMED record Report an error
Daan Gene EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	24 tests/kit5 refs98/79 Large package, 24 tests/kit98/79 Large package, 48 tests/kit98/79 Single tube, 48 tests/kit98/79	– 98/79	EUDAMED record Report an error
Molbio Diagnostics EU representative : QbD RepS BV (Belgium)	India	Truenat Influenza A/B 60120000598/79 Truenat Influenza A/B 60120002098/79 Truenat Influenza A/B 60120002598/79 Truenat Influenza A/B 60120005098/79	– 98/79	Website customersupport@molbiodiagnostics.com EUDAMED record Report an error
Ortho-Clinical Diagnostics Dba Quidel EU representative : MDSS GmbH (Germany)	United States	Lyra Influenza A+B Assay98/79 Lyra Parainfluenza Virus Assay98/79 Quidel Molecular Influenza A+B Control Set98/79 Quidel Molecular Parainfluenza Virus Control Set98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
R-Biopharm FDA	Germany	RIDA®GENE Flu98/79 RIDA®GENE Parainfluenza98/79 RIDA®UNITY Flu RIDA®UNITY Parainfluenza	B IVDR, 98/79	Website EUDAMED record Report an error
Shanghai BioGerm Medical Technology EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	6-in-1 Respiratory Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 50 tests/kit98/79 Influenza A/B & RSV Nucleic Acid Detection Kit (Fluorescent RT-MIRA) 24 tests/kit Sampling tube with 0.75mL Lysis Buffer98/79 Influenza A/B & RSV Nucleic Acid Detection Kit (Fluorescent RT-MIRA) 24 tests/kit Sampling tube with 2.5mL Lysis Buffer98/79 Respiratory Syncytial Virus/HumanParainfluenza Virus /Human Rhinovirus Nucleic Acid Detection Kit (Fluorescent RT-MIRA) 24 tests/kit98/79	– 98/79	EUDAMED record Report an error
altona Diagnostics FDA	Germany	AltoStar® Influenza Screen & Type RT-PCR Kit 1.598/79 RealStar® Influenza Screen & Type RT-PCR Kit 4.098/79 RealStar® PIV RT-PCR Kit 2.098/79	– 98/79	info@altona-diagnostics.com EUDAMED record Report an error
Bioer FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Human Parainfluenza Virus Type 1, Type 2, Type 3 Nucleic Acid Detection Kit (Fluorescence PCR) BSJ11L198/79 Human Parainfluenza Virus Type 1, Type 2, Type 3 Nucleic Acid Detection Kit (Fluorescence PCR) BSJ11M198/79 Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR) BSJ04S1, BSJ04M1, BSJ04L13 refs	B IVDR, 98/79	Website ra_oversea@bioer.com.cn EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Influenza A and B Viruses Real Time PCR Kit2 refs98/79 Influenza Virus Subtype N6 Real Time PCR Kit JC10134NW-25T98/79 Influenza Virus Subtype N6 Real Time PCR Kit JC10134NW-50T98/79	– 98/79	EUDAMED record Report an error
Certest	Spain	VIASURE Flu A + B Real Time PCR Detection Kit3 refs VIASURE Flu Typing II Real Time PCR Detection Kit3 refs VIASURE Parainfluenza Real Time PCR Detection Kit3 refs	B IVDR	Website quality@certest.es EUDAMED record Report an error
Hecin EU representative : Share info GmbH (Germany)	China	AccuProbe Influenza A Virus PCR Kit3 refs AccuProbe Influenza A/B Virus PCR Kit3 refs AccuProbe Influenza B Virus PCR Kit3 refs	B IVDR	EUDAMED record Report an error
Vitassay	Spain	Vitassay qPCR Flu A + Flu B98/79 Vitassay qPCR Parainfluenza 1-3+2-498/79 Vitassay qPCR Type I/Flu98/79	– 98/79	Website info@vitassay.com EUDAMED record Report an error
Aitbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	Singapore	30010798/79 30010898/79	– 98/79	Website EUDAMED record Report an error
Cesna	Türkiye	INFLUENZA A-B, H1N1 DETECTION KIT INFLUENZA-A,B DETECTION KIT CSNP016	B IVDR	Website info@cesna.com.tr EUDAMED record Report an error
Daltonbio EU representative : Medunion S.L. (Spain)	China	Influenza A Virus Nucleic Acid Detection Kit (Isothermal Amplification Method)98/79 Influenza B Virus Nucleic Acid Detection Kit (Isothermal Amplification Method)98/79	– 98/79	Website EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium)	United States	Panther Fusion Flu A/B/RSV Assay2 refs Panther Fusion Paraflu Assay2 refs	B IVDR	EUDAMED record Report an error
Ingenetix	Austria	ViroReal® Kit Influenza A/B98/79 ViroReal® Kit Parainfluenzavirus98/79	– 98/79	Website office@ingenetix.com EUDAMED record Report an error
Kogene EU representative : Obelis s.a. (Belgium)	South Korea	PowerChek™ Influenza B (Victoria & Yamagata) Real-time PCR Kit Ver.1.198/79 PowerChek™ Parainfluenza Virus 1/2/3 Real-time PCR Kit98/79	– 98/79	Website info@kogene.co.kr EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	4 Respiratory Pathogens Real Time RT-PCR Kit98/79 IFVA/H1N1/IFVB Test98/79	– 98/79	Website EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Influenza A (H1N1) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Influenza A+B virus Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79	– 98/79	Website sales@szzijian.com EUDAMED record Report an error
Vela Operations Singapore Pte FDA EU representative : Vela Diagnostics Germany GmbH (Germany)	Singapore	Sentosa SA Influenza A/B & 2009 H1N1 RT-PCR Test 11126798/79 Sentosa SA Influenza A/B & RSV RT-PCR Test (4x24) 30014598/79	– 98/79	Website infoAPAC@veladx.com EUDAMED record Report an error
ZeptoMetrix FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	NATtrol™ Influenza A/B Positive Control NATtrol™ Influenza/RSV Negative Control	B IVDR	Website EUDAMED record Report an error
PathoFinder	Netherlands	RealAccurate® Quadruplex Parainfluenza PCR kit PF0972-R98/79 RealAccurate® Quadruplex Influenza PCR Kit PF0970-R (no longer marketed)	B IVDR, 98/79	Website info@pathofinder.com EUDAMED record Report an error
Ab Analitica	Italy	REALQUALITY InFLU-Typing2 refs98/79	– 98/79	customersupport@abanalitica.it EUDAMED record Report an error
Advanced Molecular Diagnostics EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	ZENA MAX Influenza A(H1N1)pdm09 Real Time PCR Detection Kit98/79	– 98/79	Website info@am-diagnostics.co.uk EUDAMED record Report an error
Anchor Diagnostics	Germany	Anchor Influenza A/B PCR Kit98/79	– 98/79	info@anchor-diagnostics.com EUDAMED record Report an error
Credo Diagnostics Biomedical Pte Taiwan Branch EU representative : MedNet EC-REP GmbH (Germany)	Taiwan	VitaPCR Flu A&B Assay98/79	– 98/79	service@credodxbiomed.com EUDAMED record Report an error
Elisabeth	Czechia	EliGene® Influenza A/B/pandemic LC98/79	– 98/79	Website info@elisabeth.cz EUDAMED record Report an error
GenDx FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	GENEYE® Influenza Virus （FluA/B）ERA Assay98/79	– 98/79	EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Diagnostic Kit for Influenza A virus RNA (Fluorescence RT-PCR)98/79	– 98/79	Website EUDAMED record Report an error
Iontek	Türkiye	Fluorion Influenza A/B QLP 1.0 Real-Time PCR Kit98/79	– 98/79	Website 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
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR) HWTS-RT176A3 refs	B IVDR	marketing@hongweitest.com EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : SUNGO Europe B.V. (Netherlands)	China	Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)2 refs98/79	– 98/79	EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany)	China	Influenza A/B Virus Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	EUDAMED record Report an error
KH Medical EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	RADI FAST Influenza A/B Detection Kit98/79	– 98/79	Website info@khmedical.co.kr EUDAMED record Report an error
Lysunbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	LYSUN FLU-S21（25PCS）98/79	– 98/79	EUDAMED record Report an error
MedicalSystem Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands)	China	Influenza A+B Rapid Test Cassette 1T98/79	– 98/79	EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	EasyNAT Rapid Flu Assay	B IVDR	Website service@bioustar.com EUDAMED record Report an error
Princeton BioMeditech FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) No model still on the market	United States	BioSign Flu A&B98/79 (no longer marketed) Immunocard STAT Flu A&B98/79 (no longer marketed) Immunocard STAT Flu A&B Nasopharyngeal Wash/Aspirate accessory kit98/79 (no longer marketed) Status Flu A+B98/79 (no longer marketed)	– 98/79	Website info@pbmc.com EUDAMED record Report an error

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