Infectious diseasesOther infectious immunology/NATInfectious immunology

Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus

EMDN code W0105900102

30 manufacturers, 130 models including 115 on the market, 10 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 30

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
Jiangsu Qitian Gene biotechnology EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other	China	Bacillus anthracis Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Brucella Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 COVID-19 Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA）3 refs98/79 Ebola virus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 21 others Enterobacter Sakazakii Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Japanese Encephalitis Virus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Listeria Monocytogenes Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Mpox Virus Nucleic Acid Detection Kit（Fluorescent RAA)3 refs98/79 Plasmodium Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 RAA Nucleic Acid Amplication Kit2 refs RAA Nucleic Acid Amplication Kit(Fluorescent Method)2 refs RAA Nucleic Acid Amplication Kit(Test Strip Method)2 refs RT-RAA Nucleic Acid Amplication Kit2 refs RT-RAA Nucleic Acid Amplication Kit(Fluorescent Method)2 refs RT-RAA Nucleic Acid Amplication Kit(Test Strip Method)2 refs Salmonella Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 SARS-CoV-2 Nucleic Acid Detection Kit98/79 Schistosoma Haematobium Nucleic Acid Detection Kit（Fluorescent RAA)3 refs98/79 Schistosoma Mansoni Nucleic Acid Detection Kit（Fluorescent RAA)3 refs98/79 Staphylococcus Aureus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Vibrio Cholerae Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Vibrio Parahemolyticus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Yellow Fever Virus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Yersinia Pestis Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Zika Virus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79	A IVDR, 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 Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 -Subpackage 48 tests/kit98/79 Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 50 tests/kit98/79 Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR) 50 tests/kit98/79 Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR)-Subpackage 48 tests/kit98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Dengue virus98/79 12 others Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Enterovirus98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Influenza A virus98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Novel Coronavirus (SARS-CoV-2) 16 tests/kit98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for SARS-CoV-2 16 tests/kit98/79 Rapid identification Kit for B.1.1.7/B.1.351 and P.1 of SARS-CoV-2 (ARMS-PCR) 50 tests/kit98/79 Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens 24 tests/kit98/79 Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens 25 tests/kit98/79 Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens 48 tests/kit98/79 Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens 50tests/kit98/79 Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 50 tests/kit98/79 SARS-CoV-2 Variant B.1.617.2 Rapid Identification Kit (Fluorescence PCR) 50 tests/kit98/79 SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR) 50 tests/kit98/79	– 98/79	marketing@hongweitest.com EUDAMED record Report an error
Xiamen Zeesan Biotech FDA EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other	China	Respiratory Pathogen Panel (RPP3D)98/79 Respiratory Pathogen Panel (RPP40D)98/79 Respiratory Pathogen Panel (RPP4D)98/79 Sanity-2 Respiratory Pathogen Panel (RPP22)98/79 Sanity-2 Respiratory Pathogen Panel (RPP3)98/79 4 others Sanity-2 Respiratory Pathogen Panel (RPP4)98/79 Sanity-2 Respiratory Pathogen Panel (RPP40)98/79 SARS-CoV-2 Test Kit98/79 SARS-CoV-2 Test Kit (Sanity 2.0)4 refs98/79	– 98/79	info@zsandx.com EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi	Türkiye	Eye Infection Detection and Monitoring Kit (24)3 refs98/79 Gastrointestinal Detection and Monitoring Kit (24)3 refs98/79 Gastrointestinal Detection and Monitoring Kit (48)3 refs98/79 Gastrointestinal Detection and Monitoring Kit (96)3 refs98/79 Monkeypox Virus Detection and Monitoring Kit (24)3 refs98/79 3 others Sapovirus Detection and Monitoring Kit (24)3 refs98/79 Sapovirus Detection and Monitoring Kit (48)3 refs98/79 Urinary Tract Infection Detection and Monitoring Kit (24)3 refs98/79	– 98/79	Website EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	"AHTV01-AHG48E， AHTV01-AHG96E"98/79 ADZCOM01D-AHG48E98/79 AHTV01D-AHG48E98/79 CMTB01A-AHG4E98/79 CMTBMDR01A-AHG4E98/79 3 others CMTBMDRZK01-AHG4E98/79 CMTBRIF01A-AHG4E98/79 CMTBRIFZK01-AHG4E98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	6 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 9 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Human Parvovirus B19 DNA Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Human Rhinovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Listeria Monocytogenes Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 6 others Pneumocystis Jiroveci, Cryptococcus Neoformans and Aspergillus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Vibrio Cholerae Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Bocavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) MBGV/RVFV/CHIKV Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) Norovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) Q Fever Rickettsia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed)	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Coxsackievirus A10 Real Time RT-PCR Kit98/79 Coxsackievirus A6 Real Time RT-PCR Kit98/79 Foot-and-Mouth Disease Virus (FMDV) A Strain Real Time RT-PCR Kit98/79 Foot-and-Mouth Disease Virus (FMDV) Asia 1 Strain Real Time RT-PCR Kit98/79 Foot-and-Mouth Disease Virus (FMDV) O Strain Real Time RT-PCR Kit98/79 2 others Foot-and-Mouth Disease Virus (FMDV) Serotype A22 Real Time RT-PCR Kit98/79 Vibrio Cholerae O1/O139/CTX Lyo-PCR Kit98/79	– 98/79	Website EUDAMED record Report an error
Vitrosens	Türkiye	ChainFor™3 refs LyoSens Haemophilus Ducreyi Detection qPCR Kit LYO8198/79 LyoSens™ LYO815WS2498/79 LyoSens™ LYO81WS9698/79	C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Yzymedical EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	ATM/p53/13q14/RB1/CSP12 gene Probe Detection Kit (fluorescence in situ hybridization )98/79 HER-2 DNA Probe Kit (fluorescence in situ hybridization )98/79 i(17q) gene Probe Detection Kit (fluorescence in situ hybridization )98/79 PML/RARA Gene Fusion Probe Detection Kit (fluorescence in situ hybridization )98/79	– 98/79	EUDAMED record Report an error
Avioq Bio-tech EU representative : SUNGO Europe B.V. (Netherlands)	China	24 Tests/Kit98/79 48 Tests/Kit98/79 96 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Ant Medi̇kal İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	Laborant Omicron VariAnt RT-qPCR Kit Laborant SARS-CoV-2 RT-qPCR Kit	A IVDR	Website info@antmedical.com EUDAMED record Report an error
Beijing Healthgene Laboratory EU representative : Lotus NL B.V. (Netherlands)	China	20 Tests/Kit98/79 COVID-19 Nucleic Acid Detection Kit(Fluorescence PCR)2 refs98/79	– 98/79	EUDAMED record Report an error
Bgi	Denmark	BGI 50 tests/kit98/79 Nucleic Acid Extraction Kit 96 tests	A IVDR, 98/79	Website EUDAMED record Report an error
Bioperfectus FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Monkeypox Virus Real Time PCR Kit YJC70115NW-25T98/79 Monkeypox Virus Real Time PCR Kit YJC70115NW-50T98/79	– 98/79	EUDAMED record Report an error
Bruker FDA	Germany	Micro-Dx2 refs98/79 SepsiTest-UMD2 refs98/79	– 98/79	Website info.md@bruker.com EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)98/79 EasyNAT Vibrio Cholerae Assay98/79	– 98/79	Website service@bioustar.com EUDAMED record Report an error
3Bblackbio EU representative : Wellkang Ltd (Northern Ireland)	India	TRUPCR® Respiratory Pathogen Panel Kit3 refs	C IVDR	Website info@3bblackbio.com EUDAMED record Report an error
AD Nucleis	France	Open lyophilized One-Step qPCR Kit IVD	A IVDR	Website EUDAMED record Report an error
altona Diagnostics FDA	Germany	FlexStar® (RT-)PCR Amplification Mix 1.52 refs	A IVDR	info@altona-diagnostics.com EUDAMED record Report an error
AusDiagnostics EU representative : R-Biopharm AG (Germany)	Australia	Demi DNA Reagent Cassette3 refs	A IVDR	Website regulatory@r-biopharm.com.au EUDAMED record Report an error
Certest	Spain	VIASURE Viral Meningitis Panel Real Time PCR Detection Kit3 refs	C IVDR	Website quality@certest.es EUDAMED record Report an error
Chengdu Find Medical Devices EU representative : MedPath GmbH (Germany)	China	Cell-Free Fetal DNA Library Prepare Kit	A IVDR	EUDAMED record Report an error
Credence Genomics EU representative : Obelis s.a. (Belgium)	Sri Lanka	Bactfast CGNBF001	A IVDR	Website EUDAMED record Report an error
Hain Lifescience	Germany	Reagent Set for DNA•STRIP Kits	A IVDR	EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Lotus NL B.V. (Netherlands)	China	Human Leukocyte Antigen B27 Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)98/79	– 98/79	EUDAMED record Report an error
Qingdao Huaren Medical Product EU representative : Lotus NL B.V. (Netherlands)	China	Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)5 refs98/79	– 98/79	EUDAMED record Report an error
Hangzhou ShengTing Medical Technology EU representative : Medunion S.L. (Spain) No model still on the market	China	Mycobacterium nucleic acid and M. tuberculosis drug resistance gene detection kit V2.198/79 (no longer marketed) Mycobacterium nucleic acid and M. tuberculosis drug resistance gene detection kit V2.298/79 (no longer marketed) Mycobacterium nucleic acid and M. tuberculosis drug resistance gene detection kit V3.198/79 (no longer marketed) Smartseq-DNA&RNA detection kit V3.198/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Anouve EU representative : Obelis s.a. (Belgium) No model still on the market	China	Anouve 32 tests/box (no longer marketed) Anouve 48 tests/box (no longer marketed) Anouve 50 tests/box (no longer marketed)	A IVDR	Website 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/kit98/79 (no longer marketed) 48 tests/kit98/79 (no longer marketed) 96 tests/kit98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Biotime EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）4 refs98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

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