Beta-HCG (AuraFIA Beta-HCG ) - India CDSCO Medical Device Registration

Beta-HCG (AuraFIA Beta-HCG ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000248_fc47e5f673f2f03babf1391b79960333_1d0da924f02452c64af6f6eb73d24187. 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 C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Beta-HCG (AuraFIA Beta-HCG )

UID: IMP/IVD/2022/000248_fc47e5f673f2f03babf1391b79960333_1d0da924f02452c64af6f6eb73d24187

Brand Name

Time-resolved Fluorescence Immunochromatographic Assay

License Holder

INDO-MIM TEC PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

This kit is suitable for in vitro quantitative detection of the concentration of Human Chorionic Gonadotropin β-Subunit (Time-resolved Fluorescence Immunochromatographic Assay) in human serum, plasma and whole blood

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