T4 (AuraFIA T4 ) - India CDSCO Medical Device Registration

T4 (AuraFIA T4 ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000248_d23b2302c75666f73096b2a8d027bbd6_0638caef0b67d402a2a8cf7dbbb21ff5. This device is marketed under the brand name Time-resolved Fluorescence Immunochromatographic Assay. The license holder is INDO-MIM TEC PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

T4 (AuraFIA T4 )

UID: IMP/IVD/2022/000248_d23b2302c75666f73096b2a8d027bbd6_0638caef0b67d402a2a8cf7dbbb21ff5

Brand Name

Time-resolved Fluorescence Immunochromatographic Assay

License Holder

INDO-MIM TEC PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

This kit is suitable for in vitro quantitative detection of the concentration of tetraiodothyronine (Time-resolved Fluorescence Immunochromatographic Assay) in human serum, plasma and whole blood samples. This product is used for testing in medical and health institutions for the auxiliary diagnosis of the assessment of thyroid function

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