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Shenzhen Zijian Biotechnology Co., Ltd

China·CN-MF-000022829

Last updated September 18, 2026

About

Address:5th/7th floor, Building A1, Qiaode Science and Technology Park, Guangming District, Shenzhen, China

From the manufacturer's own website, in their original language. Source

What Shenzhen Zijian Biotechnology Co., Ltd makes

Shenzhen Zijian Biotechnology Co., Ltd manufactures diagnostic test kits for laboratory use, including fluorescence immunoassay and chemiluminescent immunoassay (CLIA) devices. Their products detect biomarkers such as creatine kinase isoenzyme (CK-MB), SARS-CoV-2 neutralizing antibodies, D-dimer, Helicobacter pylori antibodies, and cancer-related markers like CA15-3. They also supply specimen collection tools, including disposable virus sampling tubes and flocked swabs for clinical sampling.

The company’s diagnostic devices fall under Class A and Class I classifications, with some listed as In Vitro Diagnostic (IVD) General category devices. Their products are registered in the EU’s eudamed database, ensuring traceability and compliance with regulatory requirements. The manufacturer operates from China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
China
Address
502, Building A, Qiaode Science Park, No.7, Guangming Hi-tech Park West, Tianliao Community, Yutang Street, Shenzhen, China
Phone
+86-755-26614284
PRRC Contact
Jinshan Guo
EUDAMED SRN
CN-MF-000022829
FDA FEI Number
—
DUNS Number
—

Catalogue (248)

Page 1 of 5
DeviceModel / ReferenceRegistriesClassStatus
Creatine Kinase Isoenzyme (CK-MB) Detection Kit(Fluorescence Immunoassay) 18-02-0118
EUDAMED
IVD GeneralActive
SARS-CoV-2 Neutralizing Antibody Detection Kit (Fluorescence Immunoassay) 18-02-0126
EUDAMED
IVD GeneralActive
Anti-tyrosine Phosphatase 2 antibody(Anti-IA2-IgG) Detection Kit(CLIA) 18-02-0204
EUDAMED
IVD GeneralActive
D-dimer Detection Kit(Fluorescence Immunoassay) 18-02-0120
EUDAMED
IVD GeneralActive
H. Pylori Ab FIA Kit 18-02-0068
EUDAMED
IVD GeneralActive
CA15-3 FIA Kit 18-02-0045
EUDAMED
IVD GeneralActive
SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold) 18-02-0134
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0160
EUDAMED
IVD GeneralActive
D-Dimer Detection Kit(CLIA) 18-02-0142
EUDAMED
IVD GeneralActive
Human Insulin Autoantibodies (IAA) Detection Kit(CLIA) 18-02-0205
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0085
EUDAMED
Class IActive
Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method) 18-02-0025
EUDAMED
IVD GeneralActive
Testing pack A060034
EUDAMED
Class AActive
DS-DNA FIA Kit 18-02-0053
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0078
EUDAMED
Class IActive
Disposable Virus Sampling Tube 18-03-0167
EUDAMED
IVD GeneralActive
Free Thyroxine (fT4) Detection Kit(Fluorescence Immunoassay) 18-02-0108
EUDAMED
IVD GeneralActive
Vitamin B12 Detection Kit(CLIA) 18-02-0187
EUDAMED
IVD GeneralActive
Automatic Nucleic Acid Extractor 18-06-0004
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0065
EUDAMED
Class IActive
Disposable Virus Sampling Tube 18-03-0189
EUDAMED
IVD GeneralActive
Prolactin (PRL) Detection Kit(CLIA) 18-02-0152
EUDAMED
IVD GeneralActive
Full-range C-Reactive Protein (HsCRP + Conventional CRP) Detection Kit(Fluorescence Immunoassay) 18-02-0132
EUDAMED
IVD GeneralActive
Dengue NS1 Ag FIA Kit 18-02-0071
EUDAMED
IVD GeneralActive
Cardiac Troponin I(cTnI)Detection Kit(CLIA) 18-02-0136
EUDAMED
IVD GeneralActive
Multifunctional blood analyzer A060026
EUDAMED
Class AActive
Calcitonin(CT)Detection Kit(CLIA) 18-02-0189
EUDAMED
IVD GeneralActive
Anti-mullerian hormone (AMH ) Detection Kit(CLIA) 18-02-0158
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0070
EUDAMED
Class IActive
ANA Screen FIA Kit 18-02-0054
EUDAMED
IVD GeneralActive
Adenovirus FIA Kit 18-02-0066
EUDAMED
IVD GeneralActive
Mutation of SARS-CoV-2 nucleic acid Detection Kit (Real Time PCR) 18-02-0129
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0176
EUDAMED
IVD GeneralActive
Anti-Thyroid Peroxidase (Anti-TPO) Detection Kit(CLIA) 18-02-0170
EUDAMED
IVD GeneralActive
Myoglobin (MYO) Detection Kit(Fluorescence Immunoassay) 18-02-0121
EUDAMED
IVD GeneralActive
Thyroglobulin autoantibody (TGA) Detection Kit(CLIA) 18-02-0171
EUDAMED
IVD GeneralActive
Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) 18-01-0010
EUDAMED
IVD GeneralActive
Ferritin (FERR) Detection Kit(CLIA) 18-02-0188
EUDAMED
IVD GeneralActive
CEA FIA Kit 18-02-0042
EUDAMED
IVD GeneralActive
Malaria Pf/Pv Antigen Rapid Test Kit(Lateral Flow Method) 18-02-0027
EUDAMED
IVD GeneralActive
Hydroxy Vitamin D(25-OH-VD) Detection Kit(CLIA) 18-02-0185
EUDAMED
IVD GeneralActive
C-peptide (C-P) Detection Kit(CLIA) 18-02-0178
EUDAMED
IVD GeneralActive
Hydroxy Vitamin D (25-OH-D) Detection Kit(Fluorescence Immunoassay) 18-02-0115
EUDAMED
IVD GeneralActive
Ferritin(FERR) Detection Kit (Fluorescence Immunoassay) 18-02-0123
EUDAMED
IVD GeneralActive
FA FIA Kit 18-02-0064
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0185
EUDAMED
IVD GeneralActive
Methylene tetrahydrofolate reductase (MTHFR) Diagnostic Kit (PCR-Fluorescence Probing) 18-01-0016
EUDAMED
IVD GeneralActive
Cortisol Detection Kit(CLIA) 18-02-0183
EUDAMED
IVD GeneralActive
Intact Parathyroid Hormone (Intact PTH) Detection Kit(CLIA) 18-02-0190
EUDAMED
IVD GeneralActive
H. Pylori Ag FIA Kit 18-02-0067
EUDAMED
IVD GeneralActive

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