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SHANGHAI ZJ BIO-TECH CO., LTD.

China·CN-MF-000017861

Last updated September 17, 2026

Information

Country
China
Address
2168 Chenhang Road, Building #9-301-11, 2168 Chenhang Road Minhang District, Shanghai , China
LinkedIn
—
Facebook
—
Phone
+86-21-34680598
PRRC Contact
Yiyun Wang
EUDAMED SRN
CN-MF-000017861
FDA FEI Number
3007143373
DUNS Number
—

Catalogue (316)

Page 5 of 7
DeviceModel / ReferenceRegistriesClassStatus
23 HPV Genotypes Multiplex Test TD-0540-06-24
EUDAMED
IVD GeneralActive
JCV Real Time PCR Kit OD-0230-02
EUDAMED
IVD GeneralActive
High-Risk Human Papillomavirus ( HPV) and Genotyping 16&18 Diagnostic Kit(PCR-Fluorescence) TD-0413-02-25
EUDAMED
IVD GeneralActive
Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 2 Genes) RR-0508-02-48C
EUDAMED
IVD GeneralActive
Meningococcus Real Time PCR Kit RD-0058-02
EUDAMED
IVD GeneralActive
Vibrio Alginolyticus Real Time PCR Kit DD-0130-02
EUDAMED
IVD GeneralActive
Viral DNA/RNA Isolation Kit (for Auto-Extraction) ME-0096-500
EUDAMED
Class AActive
Influenza Virus C Real Time RT-PCR Kit RR-0149-02
EUDAMED
IVD GeneralActive
Varicella Zoster Virus (VZV) Real Time PCR Kit OD-0024-02
EUDAMED
IVD GeneralActive
Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 3 Genes) RR-0479-02
EUDAMED
IVD GeneralActive
Influenza Virus A H1&H3 Real Time RT-PCR Kit RR-0235-02
EUDAMED
IVD GeneralActive
Leukemia FIP1L1-PDGFRA Fusion Gene Real Time RT-PCR Kit TR-0288-02
EUDAMED
IVD GeneralActive
Leukemia CBFB-MYH11 Fusion Gene Typing Real Time RT-PCR Kit TR-0284-02
EUDAMED
IVD GeneralActive
Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 3 Genes) RR-0479-02-200
EUDAMED
IVD GeneralActive
Measles Virus Real Time RT-PCR Kit RR-0054-02
EUDAMED
IVD GeneralActive
Shigella Real Time PCR Kit DD-0033-02
EUDAMED
IVD GeneralActive
Liferiver® Preservation Solution PR-0014-100
EUDAMED
Class AActive
Coxsackie Virus Real Time RT-PCR Kit QR-0202-02
EUDAMED
IVD GeneralActive
Uterine Cervix Cancer of High-risk HPV Genotype Related Real Time PCR Kit TD-0031-02
EUDAMED
IVD GeneralActive
Avian Influenza Virus H5 Real Time RT-PCR Kit RR-0204-02
EUDAMED
IVD GeneralActive
MRSA Test DD-0431-02
EUDAMED
IVD GeneralActive
UU/MH/MG/TV Multiplex Real Time PCR Kit SD-0252-02
EUDAMED
IVD GeneralActive
Plasmodium Ovale Real Time PCR Kit ED-0215-02
EUDAMED
IVD GeneralActive
Leukemia CBFB-MYH11 D Fusion Gene Real Time RT-PCR Kit TR-0284-06
EUDAMED
IVD GeneralActive
Enterovirus 71(EV71) Real Time RT-PCR Kit QR-0205-02
EUDAMED
IVD GeneralActive
Avian Influenza Virus H5N1 Real Time RT-PCR Kit RR-0048-02
EUDAMED
IVD GeneralActive
14 RP Panel I RR-0536-02
EUDAMED
IVD GeneralActive
Viral RNA Extraction Kit (Preloaded for Auto-Extraction) ME-0093-60
EUDAMED
Class AActive
Vancomycin-Resistant Staphylococcus Aureus (VRSA) Real Time PCR Kit DD-0125-02
EUDAMED
IVD GeneralActive
Streptococcus Suis Real Time PCR Kit ZD-0069-02
EUDAMED
IVD GeneralActive
Human Bocavirus(HBoV)Real Time PCR Kit RD-0131-02
EUDAMED
IVD GeneralActive
Neisseria Gonorrhoeae (NG) Real Time PCR Kit SD-0014-02
EUDAMED
IVD GeneralActive
Respiratory Syncytial Virus (RSV) Typing A &B Real Time RT-PCR Kit RR-0326-02
EUDAMED
IVD GeneralActive
LyoHarmonyHPV Test LTD-0557-02-48
EUDAMED
IVD GeneralActive
8 Common Leukemia Fusion Genes Screening Real Time RT-PCR Kit TR-0299-02
EUDAMED
IVD GeneralActive
Leukemia M-BCR Fusion Gene Real Time RT-PCR Kit TR-0126-08
EUDAMED
IVD GeneralActive
Vibrio Cholera O1 Real Time PCR Kit DD-0123-02
EUDAMED
IVD GeneralActive
New influenza A virus(H1N1) Real Time RT-PCR Kit RR-0139-02
EUDAMED
IVD GeneralActive
Human Parainfluenza Virus Type 1 Real Time RT-PCR Kit RR-0156-02
EUDAMED
IVD GeneralActive
Enteroinvasive E.Coli (EIEC) Real Time PCR Kit DD-0093-02
EUDAMED
IVD GeneralActive
Viral RNA Isolation Kit (Preloaded for Auto-Extraction) ME-0044
EUDAMED
Class AActive
Botulinus (Types A/B/E/F) Real Time PCR Kit DD-0151-02
EUDAMED
IVD GeneralActive
Human Astrovirus (HAstV) Real Time RT-PCR Kit DR-0150-02
EUDAMED
IVD GeneralActive
SARS-CoV-2 Neutralization Antibody Detection Kit (Colloidal Gold), CG-0004-20
EUDAMED
IVD GeneralActive
MP/CP Test RD-0224-02
EUDAMED
IVD GeneralActive
Yellow Fever Virus (YFV) Real Time RT-PCR Kit ZR-0241-02
EUDAMED
IVD GeneralActive
5 Insect-borne Pathogen Detection kit E-0009-02P-24A
EUDAMED
IVD GeneralActive
7 Rodent-carrying Pathogen Detection kit R-0005-02P-12
EUDAMED
IVD GeneralActive
Nipah Virus (NiV) Real Time RT-PCR Kit ER-0170-02
EUDAMED
IVD GeneralActive
Mycoplasma Pneumoniae (MP) Real Time PCR Kit RD-0100-02
EUDAMED
IVD GeneralActive

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