Chemiluminescence Immunoassay Analyzer
- UID
- IMP/IVD/2021/000458_11b35aec2d17eca32eef1c20c1a3ce8a_0e72d9a62d7a09280bb86fa13093f1b2
- Device class
- Class A
- Brand name
- Dirui_CS 1300B
- License holder
- DiaSys Diagnostics India Private Limited
- 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, sex hormones, anemia, gastritis, liver fibrosis, renal hypertension, bone metabolism, inflammation, drug monitoring and other items
Chemiluminescence Immunoassay Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000458_11b35aec2d17eca32eef1c20c1a3ce8a_0e72d9a62d7a09280bb86fa13093f1b2. 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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