Chemiluminescence Immunoassay Analyzer - India CDSCO Medical Device Registration

Chemiluminescence Immunoassay Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000458_11b35aec2d17eca32eef1c20c1a3ce8a_0b9fc9a0e9bc0c137fae025b8879ef75. This device is marketed under the brand name Dirui_CS 1300B. The license holder is DiaSys Diagnostics India Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

Chemiluminescence Immunoassay Analyzer

UID: IMP/IVD/2021/000458_11b35aec2d17eca32eef1c20c1a3ce8a_0b9fc9a0e9bc0c137fae025b8879ef75

Brand Name

Dirui_CS 1300B

License Holder

DiaSys Diagnostics India Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

The product is a fully automated instrument for quantitative and/or qualitative analysis of chemical components in human body fluids (Dirui_CS 1300B), which can assist in the diagnosis of normal people and patients with related diseases. The product has no independent measuring function and uses the supporting immunoassay reagent kit manufactured by DIRUI to finish testing. The detectable indicators include: tumors, infectious diseases, thyroid function, myocardial markers, glucose metabolism, sexhormones, anemia, gastritis, liver fibrosis, renal hypertension, bone metabolism, inflammation, drug monitoring and other items