Chongqing iSIA BIO-Technology Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED SRN CN-MF-000003364

Devices: 356
Registrations: EUDAMED

What Chongqing iSIA BIO-Technology Co., Ltd. makes

The company produces diagnostic test kits and immunoanalyzers for cardiac biomarkers, including the N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) and Troponin I (cTnI) rapid test kits, both using quantum dot-based immunofluorescence methods. It also manufactures fluorescent immuno analyzers designed for laboratory use in detecting and quantifying these biomarkers in patient samples.

These devices fall under EU regulatory classifications of Class A and Class C, with relevant information recorded in the euDAMED database. The company is based in China and adheres to applicable regulatory requirements for in vitro diagnostic medical devices.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue356

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Company details

EUDAMED SRN: CN-MF-000003364
EUDAMED status: Active
EUDAMED registered name: Chongqing iSIA BIO-Technology Co., Ltd.
EUDAMED abbreviated name: iSIA
Registered address: No.388, Jingdongfang Avenue, 400714, Chongqing, China
Website: www.isiabio.com This website had an invalid or expired security certificate when we last checked. Last checked 18 Oct 2026.
Email: [email protected]
Phone: +8623 68277909
PRRC contact: Yunguo Zuo(public in EUDAMED)

What Chongqing iSIA BIO-Technology Co., Ltd. makes

Catalogue356

Candida IgG Antibody Rapid Test Kit (QDs Immunofluorescence Method) Ref 52W

Pregnancy-Associated Plasma Protein A (PAPP-A) Test Kit (CLIA Method) Ref 2082W

C-reactive Protein (CRP+hs-CRP) Rapid Test Kit (QDs Immunofluorescence Method) Ref 06W

IgE Test Kit (CLIA Method) Ref 2023W

Control For D-Dimer Ref 005Z

Free Triiodothyronine (FT3) Test Kit (CLIA Method) Ref 2072W

Control For sFlt-1/ PLGF Ref 042Z

High Sensitivity Troponin T(hs-cTnT) Test Kit (CLIA Method) Ref 2031W

Creatine kinase isoenzyme (CK-MB) Rapid Test Kit (QDs Immunofluorescence Method) Ref 04W

Serum Amyloid A (SAA)Rapid Test Kit (QDs Immunofluorescence Method) Ref C6W

Antistreptolysin O (ASO) Rapid Test Kit (QDs Immunofluorescence Method) Ref E1W

Fecal Occult Blood (FOB) Rapid Test Kit (QDs Immunofluorescence Method) Ref D4W

Control For Creatine Kinase Isoenzyme MB (CK-MB) /Cardiac Troponin I (cTnI)/ Myoglobin (MYO) Ref 014Z

Heparin Binding Protein (HBP) Rapid Test Kit (QDs Immunofluorescence Method) Ref 41W

Neuron-Specific Enolase (NSE) Test Kit (CLIA Method) Ref 2062W

Control For Estradiol (E2) Ref 080Z

Estradiol (E2) Rapid Test Kit (QDs Immunofluorescence Method) Ref 80W

Total Immunoglobulin E (Total IgE) Rapid Test Kit (QDs Immunofluorescence Method) Ref 93W

Alpha-Fetoprotein (AFP) Rapid Test Kit (QDs Immunofluorescence Method) Ref 70W

Free Triiodothyronine (FT3) Rapid Test Kit (QDs Immunofluorescence Method) Ref C8W

Testosterone (T) Test Kit (CLIA Method) Ref 2080W

Anti-Mullerian Hormone Test Kit (QDs Immunofluorescence Method) Ref 16W

Troponin I Rapid Test Kit (QDs Immunofluorescence Method) Ref 02W

Control For Insulin Ref 095Z

High Sensitivity Troponin T(hs-cTnT) Test Kit (CLIA Method) Ref 2031W

AMH Test Kit (CLIA Method) Ref 2332W

Allergen-Specific IgE Antibody Rapid Test Kit (FIA) Ref 4BW

LH Rapid Test Kit (QDs Immunofluorescence Method) Ref 62W

Helicobacter Pylori (H.Pylori) Antigen Rapid Test Kit (QDs Immunofluorescence Method) Ref E8W

Troponin T (cTnT) Rapid Test Kit (QDs Immunofluorescence Method) Ref 69W

Calprotectin (CAL) Rapid Test Kit (QDs Immunofluorescence Method) Ref E4W

HBP Test Kit (CLIA Method) Ref 2047W

Control For Glycosylated Hemoglobin (HbA1c) Ref 024Z

Serum Amyloid (SAA) Test Kit (CLIA Method) Ref 2009W

AMH Test Kit (CLIA Method) Ref 2032W

Carcinoembryonic Antigen (CEA) Test Kit (CLIA Method) Ref 2060W

Control For Cryptococcus Ref 048Z

Cortisol Test Kit (CLIA Method) Ref 2027W

Control For Beta2-Microglobulin (Beta2-MG) Ref 0B9Z

Unconjugated Estriol (uE3) Test Kit (CLIA Method) Ref 2081W

Testosterone Rapid Test Kit (QDs Immunofluorescence Method) Ref 78W

Control For Testosterone Ref 078Z

Fecal Occult Blood (FOB) Rapid Test Kit (QDs Immunofluorescence Method) Ref 9AW

Luteinizing Hormone (LH) Test Kit (CLIA Method) Ref 2075W

Fecal Occult Blood (FOB) Rapid Test Kit (QDs Immunofluorescence Method) Ref D4W

Cytokeratin 19-Fragment (CYFRA21-1) Test Kit (CLIA Method) Ref 2058W

Insulin-Like Growth Factor Binding Protein 3 (IGFBP-3) Rapid Test Kit (QDs Immunofluorescence Method) Ref C5W

Myoglobin (MYO) Test Kit (CLIA Method) Ref 2011W

Control For Alpha-Fetoprotein (AFP) Ref 070Z

Control For Rheumatoid Factor (RF) Ref 0D5Z

Company details

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