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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 (275)

Page 6 of 6
DeviceModel / ReferenceRegistriesClassStatus
Influenza A/B Virus Antigen Detection Kit(Fluorescence Immunoassay) 18-02-0125
EUDAMED
IVD GeneralActive
Insular Cellular antibody(ICA) Detection Kit(CLIA) 18-02-0203
EUDAMED
IVD GeneralActive
RSV FIA Kit 18-02-0065
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0072
EUDAMED
Class IActive
Double fluorescence staining solution 18-05-0026
EUDAMED
Class AActive
Monkeypox Virus Detection Kit (PCR-Fluorescence Probing) 18-01-0005
EUDAMED
IVD GeneralActive
Testing pack A060031
EUDAMED
Class AActive
Specimen Collection Flocked Swab 18-07-0068
EUDAMED
Class IActive
Multifunctional blood analyzer A060028
EUDAMED
Class AActive
Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method) 18-02-0033
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0041
EUDAMED
Class IActive
CA19-9 FIA Kit 18-02-0043
EUDAMED
IVD GeneralActive
Human Heart Fatty Acid Binding Protein (H-FABP) Detection Kit(CLIA) 18-02-0140
EUDAMED
IVD GeneralActive
Helicobacter Pylori IgG (HP IgG) Detection Kit(CLIA) 18-02-0173
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0062
EUDAMED
Class IActive
Automatic Nucleic Acid Extractor 18-06-0003
EUDAMED
IVD GeneralActive
Luteinizing Hormone (LH) Detection Kit(Fluorescence Immunoassay) 18-02-0103
EUDAMED
IVD GeneralActive
Serum Amyloid A (SAA) Detection Kit(CLIA) 18-02-0147
EUDAMED
IVD GeneralActive
Total Beta subunit of human chorionic gonadotropin (β-HCG) Detection Kit(CLIA) 18-02-0151
EUDAMED
IVD GeneralActive
Insulin-like Growth Factor 1 (IGF-1) Detection Kit(CLIA) 18-02-0195
EUDAMED
IVD GeneralActive
SARS-CoV-2(COVID-19)Antibody Rapid Detection Kit(Lateral Flow Method) 18-02-0130
EUDAMED
IVD GeneralActive
Flu A Flu B+RSV+ ADV Rapid Detection Kit(Colloidal Gold) 18-02-0098
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction or Purification Kit 18-04-0036
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0215
EUDAMED
IVD GeneralActive
Monkeypox Virus Antigen Rapid Test(Lateral Flow Method) 18-02-0101
EUDAMED
IVD GeneralActive

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