Manufacturer

Shanghai ZJ Bio-Tech

ChinaLegal entities : SHANGHAI ZJ BIO-TECH CO., LTD, Shanghai ZJ Bio-Tech Co., Ltd.

First countries of placing on the market declared in EUDAMED : Austria, Belgium, France

EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)

79 categories, 295 models including 295 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Virology - NA reagents - other	W0105040599	3 Insect-Vector Pathogens Real Time RT-PCR Kit98/79 5 Insect-borne Pathogen Detection kit2 refs98/79 7 Rodent-carrying Pathogen Detection kit98/79 8 Viral Diarrhea Pathogens Multiplex Real Time PCR Kit98/79 Anaplasma phagocytophilum Real Time PCR Kit98/79 29 others BP/CP/MP Test98/79 Coxsackie Virus A16 Real Time RT-PCR Kit98/79 Coxsackie Virus A24 Real Time RT-PCR Kit98/79 Coxsackie Virus Real Time RT-PCR Kit98/79 CYP2C19 Gene Polymorphism Real Time PCR Kit98/79 Ehrlichia Real Time PCR Kit98/79 Encephalomyocarditis virus (EMCV) Real Time RT-PCR Kit98/79 Foot-and-Mouth Disease Virus(FMDV) Real Time RT-PCR Kit98/79 Human Echovirus 30 Real Time RT-PCR Kit98/79 Human Rhinovirus (HRV) Real Time RT-PCR Kit98/79 IFVA & IFVB & H5/H7N9 Test98/79 IFVA H3 H1N1 & IFVB Test98/79 Lassa Virus (LV) Real Time RT-PCR Kit98/79 Lumpy Skin Disease Virus, Sheeppox Virus and Goatpox Virus Test98/79 Marburg Virus (MBV) Real Time RT-PCR Kit98/79 Monkeypox Virus Lyo-PCR Kit2 refs98/79 Monkeypox Virus Real Time PCR Kit98/79 Monkeypox Virus Real Time PCR Test Kit98/79 Nipah Virus (NiV) Real Time RT-PCR Kit98/79 Parechovirus Real Time RT-PCR Kit98/79 Rabies Virus Real Time RT-PCR Kit98/79 Rift Valley Fever Virus (RVFV) Real Time RT-PCR Kit98/79 Thrombocytopenia Syndrome Bunyavirus (SFTSV) Real Time RT-PCR Kit98/79 Toscana Virus (TOSV) Real Time RT-PCR Kit98/79 Transfusion-transmitted Virus (TTV) Real Time PCR Kit98/79 Vibrio Cholera CTX Gene/O1/O139 Real Time PCR Kit98/79 Yellow Fever Virus (YFV) Lyo RT-PCR Kit2 refs98/79 Yellow Fever Virus (YFV) Real Time RT-PCR Kit98/79 ZIKA and Yellow Fever Test98/79	– 98/79	EUDAMED record Report an error
Bacteriology - NA reagents - other	W0105011699	10 Viral Diarrhea Pathogens Multiplex Real Time PCR Kit98/79 Aeromonas hydrophila Real Time PCR Kit98/79 Bacillus Anthrax Real Time PCR Kit98/79 Bacillus Cereus Real Time PCR Kit98/79 Borrelia Burgdorferi (BB)Real Time PCR Kit98/79 24 others Botulinus (Types A/B/E/F) Real Time PCR Kit98/79 Burkholderia Mallei Real Time PCR Kit98/79 Burkholderia Pseudomallei Real Time PCR Kit98/79 Clostridium Perfringens Real Time PCR Kit98/79 Coxiella Burnetii Rickettsia prowazekii Rickettsia typhi Multiplex Real Time PCR Kit98/79 Enterobacter sakazakii Real Time PCR Kit98/79 Extended Spectrum Beta-Lactamases (ESBLs) Producing Bacteria Real Time PCR Kit98/79 IMP Producing Bacteria Real Time PCR Kit98/79 Klebsiella pneumoniae(Kpn) Real Time PCR Kit98/79 KPC Producing Bacteria Real Time PCR Kit98/79 Legionella Pneumophila Real Time PCR Kit98/79 Neisseria Gonorrhoeae (NG) Real Time PCR Kit98/79 New Delhi Metallo-Beta-Lactamase 1 (NDM-1) Real Time PCR Kit98/79 Salmonella & Staphylococcus Aureus & Listeria Monocytogenes Multiplex Real Time PCR Kit98/79 Salmonella & Staphylococcus Aureus & Vibrio Parahemolyticus Real Time PCR Kit98/79 Salmonella Paratyphi B Real Time PCR Kit98/79 Toxic Gene of Vibrio Parahaemolyticus Real Time PCR Kit98/79 Vibrio Alginolyticus Real Time PCR Kit98/79 Vibrio Cholera O1 Real Time PCR Kit98/79 Vibrio Cholera O139 Real Time PCR Kit98/79 Vibrio Cholera Real Time PCR Kit98/79 Vibrio Cholera （Gene CTX）Real Time PCR Kit98/79 Vibrio parahaemolyticus Real Time PCR Kit98/79 Vibrio Vulnificus Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Antibodies for subtyping of leukemia (except b-&t-cell typing)	W0103080105	8 Common Leukemia Fusion Genes Screening Real Time RT-PCR Kit98/79 Leukemia AML1-ETO Fusion Gene Real Time RT-PCR Kit98/79 Leukemia AML1-EVI1 Fusion Gene Real Time RT-PCR Kit98/79 Leukemia BCR-ABL Fusion Gene Typing Real Time RT-PCR Kit98/79 Leukemia CBFB-MYH11 A Fusion Gene Real Time RT-PCR Kit98/79 19 others Leukemia CBFB-MYH11 D Fusion Gene Real Time RT-PCR Kit98/79 Leukemia CBFB-MYH11 E Fusion Gene Real Time RT-PCR Kit98/79 Leukemia CBFB-MYH11 Fusion Gene Typing Real Time RT-PCR Kit98/79 Leukemia DEK-CAN Fusion Gene Real Time RT-PCR Kit98/79 Leukemia E2A-PBX1 Fusion Gene Real Time RT-PCR Kit98/79 Leukemia FIP1L1-PDGFRA Fusion Gene Real Time RT-PCR Kit98/79 Leukemia Gene JAK2 V617F Mutation Real Time RT-PCR Kit98/79 Leukemia M-BCR Fusion Gene Real Time RT-PCR Kit2 refs98/79 Leukemia MLL-AF4 Fusion Gene Real Time RT-PCR Kit98/79 Leukemia MLL-AF9 Fusion Gene Real Time RT-PCR Kit98/79 Leukemia MLL-ENL Fusion Gene Real Time RT-PCR Kit98/79 Leukemia mu-BCR Fusion Gene Real Time RT-PCR Kit98/79 Leukemia PML-RAR a V Fusion Gene Real Time RT-PCR Kit98/79 Leukemia PML-RARa Fusion Gene Typing Real Time RT-PCR Kit98/79 Leukemia PML-RARa L Fusion Gene Real Time RT-PCR Kit98/79 Leukemia PML-RARa S Fusion Gene Real Time RT-PCR Kit98/79 Leukemia SIL-TAL1 Fusion Gene Real Time RT-PCR Kit98/79 Leukemia TEL-AML1 Fusion Gene Real Time RT-PCR Kit98/79 Leukemia WT-1Gene Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Blood Genomic DNA Isolation Kit (Preloaded for Auto-Extraction) MVD022 refs Liferiver AU Nucleic Acid Extraction kit MVR063 refs Liferiver ® Auto AT96S A Extraction Kit2 refs Liferiver ® AutoAT96S C Extraction Kit2 refs Liferiver ® AutoEX16P A Extraction Kit2 refs 18 others Liferiver ® AutoEX36 C Extraction Kit2 refs Liferiver ® AutoEX36 D Extraction Kit2 refs Liferiver ® AutoEX36 E Extraction Kit2 refs Liferiver ® AutoEX36 F Extraction Kit2 refs Liferiver® AutoAT96P A Extraction Kit MVR102 refs Liferiver® AutoEX36 A Extraction Kit MVR012 refs Liferiver® AutoEX36 B Extraction Kit MVR092 refs Liferiver® Beads Column A Extraction Kit2 refs Liferiver® Preservation Medium MCS013 refs Liferiver® Preservation Solution ACS013 refs RNA Isolation Kit (Paramagnetic Beads Column)2 refs Viral DNA/RNA Isolation Kit (Centrifuge Column) LVN01 Viral DNA/RNA Isolation Kit (for Auto-Extraction) MVR183 refs Viral RNA Extraction Kit (for Auto-Extraction) MVR102 refs Viral RNA Extraction Kit (Preloaded for Auto-Extraction) MVR152 refs Viral RNA Extraction Kit MVR092 refs Viral RNA Isolation Kit (Preloaded for Auto-Extraction) MVR012 refs Viral Transport Medium RVR093 refs	A IVDR	EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	6 RP Panel I98/79 6 RP Panel II98/79 HRV/RSV/HMPV Multiplex Real Time RT-PCR Kit98/79 Human Parainfluenza Virus Type 1 Real Time RT-PCR Kit98/79 Human Parainfluenza Virus Type 2 Real Time RT-PCR Kit98/79 17 others Human Parainfluenza Virus Type 3 Real Time RT-PCR Kit98/79 Human Parainfluenza Virus Type 4 Real Time RT-PCR Kit98/79 Influenza Virus A Real Time RT-PCR Kit98/79 Influenza Virus A&B Real Time RT-PCR Kit98/79 Influenza Virus A,B&C Real Time RT-PCR Kit98/79 Influenza Virus B Real Time RT-PCR Kit98/79 Influenza Virus B Typing Real Time RT-PCR Kit98/79 Influenza Virus C Real Time RT-PCR Kit98/79 Influenza Virus H1 Real Time RT-PCR Kit98/79 Influenza Virus H3 Real Time RT-PCR Kit98/79 Influenza Virus A H1&H3 Real Time RT-PCR Kit98/79 N1 Gene of Influenza Virus A Real Time RT-PCR Kit98/79 N2 Gene of Influenza Virus A Real Time RT-PCR Kit98/79 N3 Gene of Influenza Virus A Real Time RT-PCR Kit98/79 N7 Gene of Influenza Virus A Real Time RT-PCR Kit98/79 New influenza A virus Real Time RT-PCR Panel98/79 New influenza A virus（H1N1） Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Various sample processing instruments - other	W02069099	Automated Nucleic Acid Extraction Instrument (EX3600) Automated Nucleic Acid Extraction Instrument (EX9600) Automated Workstation for Sample Preparation (Autra9600 Super) Autra4800 Plus Autra9600 Plus 6 others AutraMic mini4800 AutraMic mini4800 Plus AutraMicMini 3200 EX1600 Plus Life9600 Real-Time PCR System QGMate	A IVDR	EUDAMED record Report an error
Avian influenza - NA reagents	W0105040515	Avian Influenza Virus H5 Real Time RT-PCR Kit98/79 Avian Influenza Virus H5N1 Real Time RT-PCR Kit98/79 Avian Influenza Virus H7 Real Time RT-PCR Kit98/79 Avian Influenza Virus H9 Real Time RT-PCR Kit98/79 Avian Influenza Virus Real Time RT-PCR Kit98/79 4 others Human Infections with Avian Influenza A Virus (H7N9) RNA Real Time RT-PCR Kit98/79 Influenza Virus H3N2 Real time RT-PCR Kit98/79 Influenza Virus H5N1 Real Time RT-PCR Kit98/79 Influenza virus H5N2 Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Dengue virus - NA reagents	W0105040511	Dengue Fever Virus & Chikungunya Virus Real Time RT-PCR Kit98/79 Dengue Fever Virus Genotyping Ⅰ/Ⅱ/Ⅲ/Ⅳ Real Time RT-PCR Kit98/79 Dengue Virus (DENV)Lyo RT-PCR Kit98/79 Dengue Virus General-type Real Time RT-PCR Kit98/79 Dengue Virus I Real Time RT-PCR Kit98/79 3 others Dengue Virus II Real Time RT-PCR Kit98/79 Dengue Virus III Real Time RT-PCR Kit98/79 Dengue Virus IV Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	HarmoniaHPV Test3 refs98/79 High-Risk Human Papillomavirus ( HPV) and Genotyping 16&18 Diagnostic Kit(PCR-Fluorescence)3 refs98/79 High-risk Human Papillomavirus（HPV）Genotyping Real time PCR kit2 refs98/79 High-risk Human Papillomavirus（HPV）Genotyping Real time PCR kit（PCR-Fluorescence）2 refs98/79 HPV16/HPV18/HPV6+11 Multiplex Real Time PCR Kit98/79 3 others LyoHarmonyHPV Test2 refs98/79 Uterine Cervix Cancer of High-risk HPV Genotype Related Real Time PCR Kit98/79 VenusHPV Test2 refs98/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus	W0105900102	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	EUDAMED record Report an error
E. coli detection by NA reagents	W0105011503	Diarrheagenic E.coli Genotype Real Time PCR Kit98/79 E. Coli O157：H7 Real Time PCR Kit98/79 Enteroadhesive E.Coli (EAEC) Real Time PCR Kit98/79 Enterohemorrhagic E.Coli (EHEC) Real Time PCR Kit98/79 Enteroinvasive E.Coli (EIEC) Real Time PCR Kit98/79 1 other Enteropathogenic E.Coli (EPEC) Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Hsv - NA reagents	W0105040311	HSVI&II Typing Real Time PCR Kit98/79 HSVⅠ&Ⅱ Real Time PCR Kit98/79 Human Herpers Virus (HHV-6) Real Time PCR Kit98/79 Human Herpers Virus (HHV-8) Real Time PCR Kit98/79 VZV/HSV2/HSV1 Multiplex Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	Malaria Parasite Real Time PCR Kit98/79 Plasmodium Falciparum Real Time PCR Kit98/79 Plasmodium Malariae Real Time PCR Kit98/79 Plasmodium Ovale Real Time PCR Kit98/79 Plasmodium Vivax Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Streptococcal detection by NA reagents	W0105011102	Group A Streptococcus (GAS) Real Time PCR Kit98/79 Group B Streptococcus (GBS) Real Time PCR Kit98/79 Streptococcus Pneumoniae Real Time PCR Kit98/79 Streptococcus Pyogenes Real Time PCR Kit98/79 Streptococcus Suis Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Brucella - NA reagents	W0105011601	Brucella (Melitensis) Real Time PCR Kit98/79 Brucella (Ovis) Real Time PCR Kit98/79 Brucella Abortus Real Time PCR Kit98/79 Brucella Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Hepatitis e virus - NA reagents	W0105020507	HEV General Type Real Time RT-PCR Kit98/79 HEV I &III Real Time RT-PCR Kit98/79 HEV Real Time RT-PCR Kit98/79 HEV Ⅰ,Ⅱ,Ⅲ&Ⅳ Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Enterovirus - NA reagents	W0105040502	Enterovirus 70（EV70）Real Time RT-PCR Kit98/79 Enterovirus 71(EV71) Real Time RT-PCR Kit98/79 Enterovirus Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Hantavirus / bunyavirus - NA reagents	W0105040514	Hantavirus Pulmonary Syndrome Real Time RT-PCR Kit98/79 HantaVirus Renal Syndrome General-type I&II Real Time RT-PCR Kit98/79 Hantavirus Renal Syndrome Typing I&II Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents	W0105070505	Japanese Encephalitis Virus (JEV) Real Time RT-PCR Kit98/79 Meningococcus Real Time PCR Kit98/79 Tick-borne Encephalitis Virus (TBEV) Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Mycology NA reagents - other	W0105060499	Cryptococcus Neoformans Real Time PCR Kit98/79 Fungus Real Time PCR Kit98/79 Pneumocystis jirovecii Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Norovirus - NA reagents	W0105040516	NoroVirus Genogroup I Real Time RT-PCR Kit98/79 Norovirus Genogroup II Real Time RT-PCR Kit98/79 NoroVirus Real Time RT-PCR Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Rotavirus - NA reagents	W0105040506	Rotavirus (Group B) Real Time RT-PCR Kit98/79 Rotavirus (Group C) Real Time RT-PCR Kit98/79 Rotavirus Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Salmonella detection by NA reagents	W0105011003	Salmonella paratyphi Real Time PCR Kit98/79 Salmonella Real Time PCR Kit98/79 Salmonella Typhi Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Staphylococcal detection by NA reagents	W0105011203	Methicillin-resistant Staphylococcus Aureus (MRSA) Real Time PCR Kit98/79 Staphylococcus Aureus Real Time PCR Kit98/79 Vancomycin-Resistant Staphylococcus Aureus (VRSA) Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Adenovirus - NA reagents	W0105040501	Adenovirus Real Time PCR Kit98/79 Respiratory AdenoVirus Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents	W0105011607	Bordetella Pertussis & Bordetella Parapertussis Real Time PCR Kit98/79 Bordetella Pertussis Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
H. pylori detection by NA reagents	W0105010403	Helicobacter Pylori and Toxin (VacA/CagA) Real Time PCR Kit98/79 Helicobacter Pylori Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	4 Respiratory Pathogens Real Time RT-PCR Kit98/79 IFVA/H1N1/IFVB Test98/79	– 98/79	EUDAMED record Report an error
Measles - NA reagents	W0105040704	Measles Virus and Rubella Virus Real Time RT-PCR Kit98/79 Measles Virus Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Neisseria meningitidis - NA reagents	W0105011611	N.meningitides Group A Real Time PCR Kit98/79 N.meningitides Group W135 Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Other parasitology - NA reagents	W0105050399	Trypanosoma Brucei Real Time PCR Kit98/79 Trypanosoma Cruzi Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents	W0105040505	Respiratory Syncytial Virus (RSV) Typing A &B Real Time RT-PCR Kit2 refs98/79 Respiratory Syncytial Virus(RSV) Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	14 RP Panel I98/79 20 RP Panel I98/79	– 98/79	EUDAMED record Report an error
Schistosoma	W0105050206	Schistosoma Haematobium Real Time PCR Kit98/79 Schistosoma Mansoni Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Screening high-risk HPV - NA reagents	W0105041002	HPV16&18 Real Time PCR Kit98/79 Uterine Cervix Cancer of High-risk HPV Genotype Related Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Yersinia - NA reagents	W0105011606	Yersinia Enterocolitica Real Time PCR Kit98/79 Yersinia pestis Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Astrovirus - NA reagents	W0105040530	Human Astrovirus (HAstV) Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Bk virus - NA reagents	W0105040522	Polyomavirus BK (PBK) Real Time PCR Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Bocavirus - NA reagents	W0105040518	Human Bocavirus（HBoV）Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
C.difficile by NA reagents	W0105011804	Clostridium Difficile Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Campylobacter detection by NA reagents	W0105011402	Campylobacter Jejuni Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Candida albicans - NA reagents	W0105060402	Candida Albicans Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Chikungunya virus - NA reagents	W0105040525	Chikungunya Virus Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Cmv - NA reagents	W0105040205	Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Coxiella burnetii (q fever) - NA reagents	W0105011603	Coxiella burnetii Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Crimean-congo hemorrhagic fever (cchf) - NA reagents	W0105040529	Crimean-Congo Hemorrhagic Fever Virus(CCHFV) Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Cryptosporidium	W0105050207	Cryptosporidium Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Diphtheria (corynebacterium d.) - NA reagents	W0105011608	Bacillus Diphtheriae Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Distomatosis	W0105050203	Schistosomiasis Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
E. coli reagents - other	W0105011599	Enterotoxigenic E. Coli (ETEC) Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Ebola (filovirus) - NA reagents	W0105040528	Ebola Virus (EBOV) Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Ebv - NA reagents	W0105040403	EBV Real Time PCR Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents	W0105070504	Salmonella & Shigella Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Haemophilus influenzae - NA reagents	W0105011610	Hemophilus Influenza B Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Hantavirus / bunyavirus	W0105040614	Hantavirus Renal Syndrome Type II Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Hepatitis a virus - NA reagents	W0105020105	HAV Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Hepatitis g virus - NA reagents	W0105020606	HGV Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Human metapneumovirus - NA reagents	W0105040517	Human Metapneumovirus (hMPV) Real Time RT-PCR kit98/79	– 98/79	EUDAMED record Report an error
IVD instruments - other	W0299	EX1600	A IVDR	EUDAMED record Report an error
Jc virus - NA reagents	W0105040523	JCV Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Leptospira	W0105011704	Leptospira Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Listeria detection by NA reagents	W0105011305	Listeria Monocytogenes Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Mumps / parotitis - NA reagents	W0105040804	Mumps Virus Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	Mycobacterium Tuberculosis (TB) Real Time PCR Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	QG28800	A IVDR	EUDAMED record Report an error
Other HPV - NA reagents	W0105041005	HPV6&11 Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Parechovirus - NA reagents	W0105040521	Human Parvovirus (B19) Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Post-analysis sample archiving systems - other	W02060299	AutraMate	A IVDR	EUDAMED record Report an error
Pseudomonas aeruginosa reagents - other	W0105010999	Pseudomonas Aeruginosa Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Rickettsia - NA reagents	W0105011605	Rickettsia Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Rubella - NA reagents	W0105040104	Rubella Virus Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Shigella - NA reagents	W0105011614	Shigella Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	4 STIs Pathogens Lyo Multiplex Test98/79	– 98/79	EUDAMED record Report an error
Strep. pneumoniae detection by NA reagents	W0105011105	Streptococcus Suis Type 2 Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Syphilis detection by NA reagents	W0105010305	Treponema Pallidum (TP) Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Varicella zoster - NA reagents	W0105040904	Varicella Zoster Virus (VZV) Real Time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Virology reagents - other	W01050499	Sendai Virus Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
West nile virus - NA reagent	W0105040526	West Nile Virus Real Time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Zika virus - NA reagents	W0105040531	Zika Virus (ZIKV) Real Time RT-PCR Kit2 refs98/79	– 98/79	EUDAMED record Report an error

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