Ichroma TSH - India CDSCO Medical Device Registration

Ichroma TSH is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000059_122161e29907100ae67784bf7c532ca8_94fd141df72b0132a1586db97edca672. This device is marketed under the brand name ichroma™ ST2. The license holder is Kin Diagnostics, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Ichroma TSH

UID: IMP/IVD/2020/000059_122161e29907100ae67784bf7c532ca8_94fd141df72b0132a1586db97edca672

Brand Name

ichroma™ ST2

License Holder

Kin Diagnostics

Device Class

Class B

Approving Authority

CDSCO

Product Information

ichroma™ TSH Plus is a fluorescence Immunoassay (ichroma™ ST2) for the quantitative determination of TSH in human whole blood/ serum/ plasma. It is useful as an aid in management and monitoring of measurement in the assessment of thyroid function. For in vitro diagnostic use only. ,ichroma Vitamin D(ichroma™ ST2)-ichroma Vitamin D is a fluorescence Immunoassay (ichroma™ ST2) for the quantitative determination of total 25(ichroma™ ST2)D2/D3 level in human serum/plasma. It is useful as an aid in management and monitoring of regulating the concentration of calcium and phosphate in the bloodstream and promoting the healthy growth and remodeling of bone. For in vitro diagnostic use only