Fully Automatic Chemiluminescence immunoassay Analyzer - India CDSCO Medical Device Registration

Fully Automatic Chemiluminescence immunoassay Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000089_7c5df50c4ac0f7ce8980c826154a14fd_e34dc4cb5b406f63425785feda54720a. This device is marketed under the brand name Mispa i700. The license holder is M/S Agappe Diagnostics Ltd, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

Fully Automatic Chemiluminescence immunoassay Analyzer

UID: IMP/IVD/2023/000089_7c5df50c4ac0f7ce8980c826154a14fd_e34dc4cb5b406f63425785feda54720a

Brand Name

Mispa i700

License Holder

M/S Agappe Diagnostics Ltd

Device Class

Class A

Approving Authority

CDSCO

Product Information

The analyzer adopts direct chemiluminescence method based on acridinium ester, and works clinically with supporting reagents for qualitative or quantitative testing of analytes in human serum, plasma, whole blood and urine samples, including vitamins detection, amino acids and blood drug concentrations detection, hormones detection, myocardial disease detection, infectious disease detection, auto-antibody detection, tumor-related antigens detection, proteins and polypeptides detection, kidney disease and liver disease detection, and immune function detection, experimental diagnosis of kidney disease.