Chongqing iSIA BIO-Technology Co., Ltd.

China Last updated 21 Oct 2026

Devices: 356
Registries: EUDAMED
FDA recalls: 0

Catalogue356

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Showing 1-50 of 356

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CMC Medical Devices & Drugs SL ES

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.

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

Frequently asked questions

How many devices does Chongqing iSIA BIO-Technology Co., Ltd. have in the registry?

The registry currently lists 356 devices for Chongqing iSIA BIO-Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Chongqing iSIA BIO-Technology Co., Ltd.'s devices?

Among its 50 most recently registered devices, Chongqing iSIA BIO-Technology Co., Ltd. has devices listed in EUDAMED (50 devices).

What risk classes do Chongqing iSIA BIO-Technology Co., Ltd.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Chongqing iSIA BIO-Technology Co., Ltd.'s devices are IVD general. Each device page shows its own class and authorisation.

What are the newest devices from Chongqing iSIA BIO-Technology Co., Ltd. in the registry?

The most recently registered devices listed for Chongqing iSIA BIO-Technology Co., Ltd. include Control For LH, Cytokeratin 19-Fragment (CYFRA21-1) Test Kit (CLIA Method), Control For Gastrin-17 (G-17) and IgE Test Kit (CLIA Method).

Generated automatically from registry data and not verified by a human reviewer.

Information

Address: No.388, Jingdongfang Avenue, 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
EUDAMED SRN: CN-MF-000003364

Catalogue356

Control For LH Ref 062Z

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

Control For Gastrin-17 (G-17) Ref 012Z

IgE Test Kit (CLIA Method) Ref 2023W

Cystatin C (Cys-C) Test Kit (CLIA Method) Ref 2046W

Ferritin Rapid Test Kit (QDs Immunofluorescence Method) Ref 13W

Control For Anti-Mullerian Hormone (AMH) Ref 016Z

Insulin-Like Growth Factor I (IGF-1) Rapid Test Kit (QDs Immunofluorescence Method) Ref C4W

Pepsinogen II (PG II) Test Kit (CLIA Method) Ref 2002W

FSH Rapid Test Kit (QDs Immunofluorescence Method) Ref 61W

Control For Total Triiodothyronine (TT3) Ref 067Z

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

D-dimer Rapid Test Kit (QDs Immunofluorescence Method) Ref 05W

Rheumatoid Factor (RF) Test Kit (CLIA Method) Ref 2041W

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

Growth Stimulation Expressed Gene 2 (ST2) Rapid Test Kit (QDs Immunofluorescence Method) Ref 20W

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

Glycosylated hemoglobin Test Kit (QDs Immunofluorescence Method) Ref 24W

Carbohydrate Antigen 125 (CA125) Test Kit (CLIA Method) Ref 2059W

Control For Total Thyroxine (TT4) Ref 068Z

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

Control For Osteocalcin (OC) Ref 022Z

Respiratory Syncytial Virus (RSV) Antigen Rapid Test Kit (QDs Immunofluorescence Method) Ref 57W

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

Cystatin C (Cys-C) Rapid Test Kit (QDs immunofluorescence Method) Ref B7W

Procalcitonin (PCT) Test Kit (CLIA Method) Ref 2007W

Control For Beta-HCG Ref 060Z

Control For Cystatin C (Cys-C) Ref 0B7Z

Control For FSH Ref 061Z

Interleukin 6 (IL-6)/ Procalcitonin (PCT) Combined Test Kit (QDs Immunofluorescence Method） Ref 18W

Aspergillus Galactomannan Rapid Test Kit (QDs Immunofluorescence Method) Ref 49W

Control For Vitamin B12 Ref 0A3Z

Human Growth Hormone (HGH) Rapid Test Kit (QDs Immunofluorescence Method) Ref C3W

Whole Parathyroid Hormone (PTH) Test Kit (CLIA Method) Ref 2005W

SARS-CoV-2 Antigen Rapid Test Kit (QDs Immunofluorescence Method) Ref 47W

Adrenocorticotropic Hormone (ACTH) Test Kit (CLIA Method) Ref 2026W

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

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

Progesterone Rapid Test Kit (QDs Immunofluorescence Method) Ref 79W

Respiratory Syncytial Virus (RSV) Antigen Rapid Test Kit (QDs Immunofluorescence Method) Ref 57W

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

Prolactin (PRL) Test Kit (CLIA Method) Ref PRL-CLIA

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

Control For Adenovirus antigen Ref 058Z

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

HBP Test Kit (CLIA Method) Ref 2047W

Prolactin (PRL) Test Kit (CLIA Method) Ref 2077W

Control For Parathyroid Hormone (PTH) Ref 008Z

Gastrin-17 Test Kit (QDs Immunofluorescence Method) Ref 12W

Adenovirus Antigen Rapid Test Kit (QDs Immunofluorescence Method) Ref 58W

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

Frequently asked questions

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