Random-access chemiluminescence immunoassay system
- UID
- IMP/IVD/2019/000206_712717ebbbb045183c01bf62a37dd2d8_cfbd8f6c95dd18f71acd283a13ced2f4
- Device class
- Class A
- Brand name
- HumaCLIA 150
- License holder
- M/s Stedman Pharmaceuticals Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- HumaCLIA 150 is an automated random-access chemiluminescent immuno-assay (HumaCLIA 150 ) IVD instrument for quantitative, semi-quantitative and qualitative determination of levels or activity of various parameters in human serum, plas-ma, or urine. In combination with HUMAN’s CLIA reagents, it may be used as aid to diagnosis, for screening or monitoring of a range of medical conditions, depending on the used reagent. HumaCLIA 150 is a closed system and can be used with predefined HUMAN CLIA reagents only. For laboratory professional use only
Random-access chemiluminescence immunoassay system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000206_712717ebbbb045183c01bf62a37dd2d8_cfbd8f6c95dd18f71acd283a13ced2f4. This device is marketed under the brand name HumaCLIA 150 . The license holder is M/s Stedman Pharmaceuticals Pvt. Ltd., and it is classified as Device Class Class A. The approving authority is CDSCO.
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