EU Manufacturer 🇨🇳 China Active

SHANGHAI ZJ BIO-TECH CO., LTD

SRN: CN-MF-000017861 · No. 20 and 21 Building, 528 Ruiqing Road, Zhangjiang High-tech Industrial East District 528 Ruiqing Road, 201203 Shanghai, China
Basic UDI-DIs
297
Total Devices
326
On Market
326
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
0

Basic Information

Address
No. 20 and 21 Building, 528 Ruiqing Road, Zhangjiang High-tech Industrial East District 528 Ruiqing Road, 201203 Shanghai, China

Regulatory Overview

Regulation
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Eu Ivdd 274
Eu Ivdr 23
Classification
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Eu Ivd General 272
Eu Ivd Class A 23
Eu Ivd Annex 2 List B 2
Device Types
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Certificate Health

Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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Type Number Expiry Date Status
IVDD Annex IV (excluding sections 4, 6) HL2164326-1 May 26, 2025

Device Portfolio

Name
10 Viral Diarrhea Pathogens Multiplex Real Time PCR Kit
14 RP Panel I
20 RP Panel I
5 Insect-borne Pathogen Detection kit
5 Insect-borne Pathogen Detection kit
6 RP Panel I
6 RP Panel II
7 Rodent-carrying Pathogen Detection kit
8 Common Leukemia Fusion Genes Screening Real Time RT-PCR Kit
8 Viral Diarrhea Pathogens Multiplex Real Time PCR Kit
Adenovirus Real Time PCR Kit
Anaplasma phagocytophilum Real Time PCR Kit
Avian Influenza Virus H5 Real Time RT-PCR Kit
Avian Influenza Virus H5N1 Real Time RT-PCR Kit
Avian Influenza Virus H7 Real Time RT-PCR Kit
Avian Influenza Virus H9 Real Time RT-PCR Kit
Avian Influenza Virus Real Time RT-PCR Kit
Bacillus Anthrax Real Time PCR Kit
Bacillus Cereus Real Time PCR Kit
Bacillus Diphtheriae Real Time PCR Kit
Blood Genomic DNA Isolation Kit (Preloaded for Auto-Extraction)
Blood Genomic DNA Isolation Kit (Preloaded for Auto-Extraction)
Bordetella Pertussis & Bordetella Parapertussis Real Time PCR Kit
Bordetella Pertussis Real Time PCR Kit
Borrelia Burgdorferi (BB)Real Time PCR Kit
Botulinus (Types A/B/E/F) Real Time PCR Kit
Brucella Real Time PCR Kit
CYP2C19 Gene Polymorphism Real Time PCR Kit
Campylobacter Jejuni Real Time PCR Kit
Candida Albicans Real Time PCR Kit
Chikungunya Virus Real Time RT-PCR Kit
Clostridium Difficile Real Time PCR Kit
Clostridium Perfringens Real Time PCR Kit
Coxiella Burnetii Rickettsia prowazekii Rickettsia typhi Multiplex Real Time PCR Kit
Coxiella burnetii Real Time PCR Kit
Coxsackie Virus A16 Real Time RT-PCR Kit
Coxsackie Virus A24 Real Time RT-PCR Kit
Coxsackie Virus Real Time RT-PCR Kit
Crimean-Congo Hemorrhagic Fever Virus(CCHFV) Real Time RT-PCR Kit
Cryptococcus Neoformans Real Time PCR Kit
Cryptosporidium Real Time PCR Kit
Dengue Fever Virus & Chikungunya Virus Real Time RT-PCR Kit
Dengue Fever Virus Genotyping â… /â…¡/â…¢/â…£ Real Time RT-PCR Kit
Dengue Virus (DENV)Lyo RT-PCR Kit
Dengue Virus General-type Real Time RT-PCR Kit
Dengue Virus I Real Time RT-PCR Kit
Dengue Virus II Real Time RT-PCR Kit
Dengue Virus III Real Time RT-PCR Kit
Dengue Virus IV Real Time RT-PCR Kit
Diarrheagenic E.coli Genotype Real Time PCR Kit