Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

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 (253)

Page 3 of 6
DeviceModel / ReferenceRegistriesClassStatus
Interleukin 6 (IL-6) Detection Kit(Fluorescence Immunoassay) 25 Tests/kit
EUDAMED
IVD GeneralActive
SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method) 18-02-0018
EUDAMED
IVD GeneralActive
Vitamin B12 Detection Kit(Fluorescence Immunoassay) 18-02-0116
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0142
EUDAMED
IVD GeneralActive
DHEA-S FIA Kit 18-02-0049
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0188
EUDAMED
IVD GeneralActive
Testing pack A060032
EUDAMED
Class AActive
Influenza A+B virus Diagnostic Kit (PCR-Fluorescence Probing) 18-01-0012
EUDAMED
IVD GeneralActive
Angio-I(A I) Detection Kit(CLIA) 18-02-0180
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0178
EUDAMED
IVD GeneralActive
SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit (Lateral Flow Method) 18-02-0038
EUDAMED
IVD GeneralActive
Tissue plasminogen activator-Plasminogen activator inhibitor Complex(t-PAIC) Detection Kit(CLIA) 18-02-0200
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0165
EUDAMED
IVD GeneralActive
Proinsulin(Pro-INS) Detection Kit(CLIA) 18-02-0176
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction or Purification Kit 18-04-0020
EUDAMED
IVD GeneralActive
Testosterone(T)Detection Kit(CLIA) 18-02-0155
EUDAMED
IVD GeneralActive
Coxsackie virus group A type 16 & enterovirus type 71 Diagnostic Kit (PCR-Fluorescence Probing) 18-01-0021
EUDAMED
IVD GeneralActive
C-peptide FIA Kit 18-02-0062
EUDAMED
IVD GeneralActive
Fluorescent biological microscope 29-05-0004
EUDAMED
Class AActive
Thrombomodulin(TM) Detection Kit(CLIA) 18-02-0199
EUDAMED
IVD GeneralActive
AFP FIA Kit 18-02-0041
EUDAMED
IVD GeneralActive
Luteinizing Hormone (LH) Detection Kit(CLIA) 18-02-0150
EUDAMED
IVD GeneralActive
GH FIA Kit 18-02-0076
EUDAMED
IVD GeneralActive
Dehydroepiandrosterone and its sulfate (DHEA-S) Detection Kit(CLIA) 18-02-0156
EUDAMED
IVD GeneralActive
Inhibin B(INH-B)Detection Kit(CLIA) 18-02-0161
EUDAMED
IVD GeneralActive
Anti-mullerian hormone (AMH) Detection Kit(Fluorescence Immunoassay) 18-02-0113
EUDAMED
IVD GeneralActive
Influenza A+B virus & 2019-nCoV (2019-nCoV orf1ab/N Gene) Diagnostic Kit (PCR-Fluorescence Probing) 18-01-0014
EUDAMED
IVD GeneralActive
Enterovirus Universal Diagnostic Kit (PCR-Fluorescence Probing) 18-01-0018
EUDAMED
IVD GeneralActive
Malaria Pf/Pv Antigen Rapid Test Kit(Lateral Flow Method) 18-02-0026
EUDAMED
IVD GeneralActive
Methylene tetrahydrofolate reductase (MTHFR) Diagnostic Kit (PCR-Fluorescence Probing) 18-01-0017
EUDAMED
IVD GeneralActive
Procalcitonin(PCT) Detection Kit(CLIA) 18-02-0144
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0043
EUDAMED
Class IActive
2019-nCoV Nucleic acid Detection Kit (Real Time PCR) 18-02-0127
EUDAMED
IVD GeneralActive
Cys-C FIA Kit 18-02-0060
EUDAMED
IVD GeneralActive
Interleukin 6 (IL-6) Detection Kit(CLIA) 18-02-0145
EUDAMED
IVD GeneralActive
Adrendcorticotrophic Hormone(ACTH)Detection Kit(CLIA) 18-02-0184
EUDAMED
IVD GeneralActive
Fungal fluorescence staining solution 18-05-0030
EUDAMED
Class AActive
Specimen Collection Flocked Swab 18-07-0052
EUDAMED
Class IActive
Disposable Virus Sampling Tube 18-03-0211
EUDAMED
IVD GeneralActive
Progesterone (P) Detection Kit(Fluorescence Immunoassay) 18-02-0111
EUDAMED
IVD GeneralActive
Double fluorescence staining solution 18-05-0028
EUDAMED
Class AActive
Disposable Virus Sampling Tube 18-03-0200
EUDAMED
IVD GeneralActive
Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing) 18-01-0015
EUDAMED
IVD GeneralActive
Free Thyroxine (fT4) Detection Kit(CLIA) 18-02-0166
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0169
EUDAMED
IVD GeneralActive
Thyroid Stimulating Hormone (TSH) Detection Kit(Fluorescence Immunoassay) 18-02-0109
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction or Purification Kit 18-04-0037
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0051
EUDAMED
Class IActive
Free Triiodothyronine (fT3) Detection Kit(Fluorescence Immunoassay) 18-02-0107
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0036
EUDAMED
Class IActive

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.