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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 2 of 7
DeviceModel / ReferenceRegistriesClassStatus
Enterovirus Real Time RT-PCR Kit QR-0206-02
EUDAMED
IVD GeneralActive
Campylobacter Jejuni Real Time PCR Kit DD-0040-02
EUDAMED
IVD GeneralActive
Dengue Virus III Real Time RT-PCR Kit ER-0064-02
EUDAMED
IVD GeneralActive
Diarrheagenic E.coli Genotype Real Time PCR Kit DD-0471-02
EUDAMED
IVD GeneralActive
Novel Coronavirus (SARS-CoV-2) Real-Time Multiplex RT-PCR Kit (RR-0487-02) RR-0487-02-50
EUDAMED
IVD GeneralActive
Automated Nucleic Acid Extraction Instrument(EX1600) ZJYY-D-10075E
EUDAMED
Class AActive
Leukemia PML-RAR a V Fusion Gene Real Time RT-PCR Kit TR-0280-08
EUDAMED
IVD GeneralActive
Bacillus Anthrax Real Time PCR Kit ZD-0073-02
EUDAMED
IVD GeneralActive
8 Viral Diarrhea Pathogens Multiplex Real Time PCR Kit DR-0505-02
EUDAMED
IVD GeneralActive
Norovirus Genogroup II Real Time RT-PCR Kit DR-0231-02
EUDAMED
IVD GeneralActive
Leukemia MLL-AF9 Fusion Gene Real Time RT-PCR Kit TR-0296-02
EUDAMED
IVD GeneralActive
Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit E-OD-0022-02-24
EUDAMED
IVD Annex II List BActive
Influenza Virus B Real Time RT-PCR Kit RR-0053-02
EUDAMED
IVD GeneralActive
Pneumocystis jirovecii Real Time PCR Kit QD-0082-02
EUDAMED
IVD GeneralActive
N3 Gene of Influenza Virus A Real Time RT-PCR Kit RR-0322-02
EUDAMED
IVD GeneralActive
20 RP Panel I R-0027-02P-12A
EUDAMED
IVD GeneralActive
Bacillus Cereus Real Time PCR Kit DD-0042-02
EUDAMED
IVD GeneralActive
Monkeypox Virus Real Time PCR Test Kit ZD-1576-02-25
EUDAMED
IVD GeneralActive
Polyomavirus BK (PBK) Real Time PCR Kit OD-0102-02
EUDAMED
IVD GeneralActive
Leukemia PML-RARa S Fusion Gene Real Time RT-PCR Kit TR-0280-06
EUDAMED
IVD GeneralActive
CYP2C19 Gene Polymorphism Real Time PCR Kit TD-0327-02
EUDAMED
IVD GeneralActive
Tick-borne Encephalitis Virus (TBEV) Real Time RT-PCR Kit ER-0172-02
EUDAMED
IVD GeneralActive
GAPDH(Human) Real Time RT-PCR Kit QR-0132-02
EUDAMED
IVD GeneralActive
Coxiella Burnetii Rickettsia prowazekii Rickettsia typhi Multiplex Real Time PCR Kit ED-0317-02
EUDAMED
IVD GeneralActive
Viral RNA Extraction Kit (Preloaded for Auto-Extraction) ME-0093-240
EUDAMED
Class AActive
Liferiver Influenza and COVID-19 Real Time Multiplex RT-PCR Kit RR-0491-02-50
EUDAMED
IVD GeneralActive
Ehrlichia Real Time PCR Kit ZD-0196-02
EUDAMED
IVD GeneralActive
Leukemia CBFB-MYH11 E Fusion Gene Real Time RT-PCR Kit TR-0284-08
EUDAMED
IVD GeneralActive
NoroVirus Real Time RT-PCR Kit DR-0325-02
EUDAMED
IVD GeneralActive
Leukemia TEL-AML1 Fusion Gene Real Time RT-PCR Kit TR-0287-02
EUDAMED
IVD GeneralActive
Human Herpers Virus (HHV-6) Real Time PCR Kit OD-0169-02
EUDAMED
IVD GeneralActive
Liferiver® Beads Column A Extraction Kit ME-0220-25
EUDAMED
Class AActive
Hantavirus Renal Syndrome Typing I&II Real Time RT-PCR Kit QR-0089-03
EUDAMED
IVD GeneralActive
Influenza Virus H1 Real Time RT-PCR Kit RR-0052-02
EUDAMED
IVD GeneralActive
Leukemia BCR-ABL Fusion Gene Typing Real Time RT-PCR Kit TR-0126-02
EUDAMED
IVD GeneralActive
Vibrio parahaemolyticus Real Time PCR Kit DD-0038-02
EUDAMED
IVD GeneralActive
Chikungunya Virus Real Time RT-PCR Kit ER-0067-02
EUDAMED
IVD GeneralActive
Ureaplasma parvum (UP) Real Time PCR Kit SD-0267-02
EUDAMED
IVD GeneralActive
Leukemia MLL-ENL Fusion Gene Real Time RT-PCR Kit TR-0298-02
EUDAMED
IVD GeneralActive
Anaplasma phagocytophilum Real Time PCR Kit ZD-0161-02
EUDAMED
IVD GeneralActive
Salmonella paratyphi Real Time PCR Kit DD-0037-02
EUDAMED
IVD GeneralActive
Leukemia DEK-CAN Fusion Gene Real Time RT-PCR Kit TR-0286-02
EUDAMED
IVD GeneralActive
Vibrio Cholera Real Time PCR Kit DD-0032-02
EUDAMED
IVD GeneralActive
Dengue Virus I Real Time RT-PCR Kit ER-0063-02
EUDAMED
IVD GeneralActive
Monkeypox Virus Real Time PCR Kit ZD-0076-02
EUDAMED
IVD GeneralActive
Human Parainfluenza Virus Type 4 Real Time RT-PCR Kit RR-0159-02
EUDAMED
IVD GeneralActive
HPV16&18 Real Time PCR Kit TD-0030-02
EUDAMED
IVD GeneralActive
HSVI&II Typing Real Time PCR Kit SD-0136-02
EUDAMED
IVD GeneralActive
Treponema Pallidum (TP) Real Time PCR Kit SD-0019-02
EUDAMED
IVD GeneralActive
Yellow Fever Virus (YFV) Lyo RT-PCR Kit LZR-0519-02-96
EUDAMED
IVD GeneralActive

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