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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 (253)

Page 4 of 6
DeviceModel / ReferenceRegistriesClassStatus
Disposable Virus Sampling Tube 18-03-0205
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction or Purification Kit 18-04-0023
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0035
EUDAMED
Class IActive
N-terminal Pro Brain Natriuretic Peptide (NT-proBNP) Detection Kit(Fluorescence Immunoassay) 18-02-0119
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction or Purification Kit 18-04-0019
EUDAMED
IVD GeneralActive
SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit(Fluorescence Immunoassay) 18-02-0207
EUDAMED
IVD GeneralActive
Insulin (INS) Detection Kit(CLIA) 18-02-0177
EUDAMED
IVD GeneralActive
Gastric proteogen 2 (PG II) Detection Kit(CLIA) 18-02-0175
EUDAMED
IVD GeneralActive
Flu A & Flu B Antigen Rapid Detection Kit (Lateral Flow Method) 18-02-0030
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0042
EUDAMED
Class IActive
Procalcitonin (PCT) Detection Kit(Fluorescence Immunoassay) 18-02-0131
EUDAMED
IVD GeneralActive
RF-IgM FIA Kit 18-02-0051
EUDAMED
IVD GeneralActive
15 High-risk HPV DNA Diagnostic Kit(type16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68) (PCR-Fluorescence Probing) 18-01-0009
EUDAMED
IVD GeneralActive
Intact-PTH FIA Kit 18-02-0063
EUDAMED
IVD GeneralActive
Semi-auto Chemistry Analyzer 29-06-0002
EUDAMED
Class AActive
Follicle Stimulating Hormone (FSH) Detection Kit(CLIA) 18-02-0149
EUDAMED
IVD GeneralActive
α2-plasmininhibitor-Plasmin Complex(PIC) Detection Kit(CLIA) 18-02-0198
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0059
EUDAMED
Class IActive
Myoglobin(MyO)Detection Kit(CLIA) 18-02-0138
EUDAMED
IVD GeneralActive
Heparin-binding Protein(HBP)Detection Kit(CLIA) 18-02-0148
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0190
EUDAMED
IVD GeneralActive
Testosterone (T) Detection Kit(Fluorescence Immunoassay) 18-02-0110
EUDAMED
IVD GeneralActive
Thyroid Stimulating Hormone (TSH) Detection Kit(CLIA) 18-02-0163
EUDAMED
IVD GeneralActive
Free estriol(FE3) Detection Kit(CLIA) 18-02-0160
EUDAMED
IVD GeneralActive
Anti-CCP FIA Kit 18-02-0052
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0038
EUDAMED
Class IActive
Disposable Virus Sampling Tube 18-03-0166
EUDAMED
IVD GeneralActive
ST2 FIA Kit 18-02-0056
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0199
EUDAMED
IVD GeneralActive
Glutamic Acid Decarboxylase Antibody (GAD65) Detection Kit(CLIA) 18-02-0202
EUDAMED
IVD GeneralActive
CA125 FIA Kit 18-02-0044
EUDAMED
IVD GeneralActive
Specimen Collection Flocked Swab 18-07-0069
EUDAMED
Class IActive
H-FABP FIA Kit 18-02-0057
EUDAMED
IVD GeneralActive
Insulin FIA Kit 18-02-0061
EUDAMED
IVD GeneralActive
Salmonella IgM FIA Kit 18-02-0073
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction or Purification Kit 18-04-0021
EUDAMED
IVD GeneralActive
Calprotectin FIA Kit 18-02-0074
EUDAMED
IVD GeneralActive
Respiratory Syncytial Virus IgM (RSV-IgM) Detection Kit(CLIA) 18-02-0191
EUDAMED
IVD GeneralActive
Malaria Pf/Pv Antigen Rapid Test Kit(Lateral Flow Method) 18-02-0028
EUDAMED
IVD GeneralActive
Disposable Virus Sampling Tube 18-03-0162
EUDAMED
IVD GeneralActive
CA72-4 FIA Kit 18-02-0046
EUDAMED
IVD GeneralActive
Thyroxine (T4) Detection Kit(Fluorescence Immunoassay) 18-02-0106
EUDAMED
IVD GeneralActive
17α-Hydroxyprogesterone Detection Kit(CLIA) 18-02-0157
EUDAMED
IVD GeneralActive
Multifunctional blood analyzer A060029
EUDAMED
Class AActive
FOB FIA Kit 18-02-0047
EUDAMED
IVD GeneralActive
Angio-II(A II) Detection Kit(CLIA 18-02-0181
EUDAMED
IVD GeneralActive
Fluorescent biological microscope 29-05-0006
EUDAMED
Class AActive
Creatine Kinase Isoenzyme (CK-MB) Detection Kit(CLIA) 18-02-0139
EUDAMED
IVD GeneralActive
Free β-subunit of human chorionic gonadotropin(free β-HCG) Detection Kit(CLIA) 18-02-0159
EUDAMED
IVD GeneralActive
HPV (Type 16 and 18) DNA Fluorescence Diagnostic Kit(PCR-Fluorescence Probing) 18-01-0008
EUDAMED
IVD GeneralActive

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