Serum Amyloid A (AuraFIA Serum Amyloid A ) - India CDSCO Medical Device Registration

Serum Amyloid A (AuraFIA Serum Amyloid A ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000248_7f69085727f49e2ca08f9bb2272ae11d_7aa4ec2c384dd0a1aa9e9e6d5f33a6db. 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

Serum Amyloid A (AuraFIA Serum Amyloid A )

UID: IMP/IVD/2022/000248_7f69085727f49e2ca08f9bb2272ae11d_7aa4ec2c384dd0a1aa9e9e6d5f33a6db

Brand Name

Time-resolved Fluorescence Immunochromatographic Assay

License Holder

INDO-MIM TEC PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

This test is suitable for in vitro quantitative detection of the concentration of human serum amyloid A (Time-resolved Fluorescence Immunochromatographic Assay) in human serum, plasma, whole blood. The product is used for auxiliary diagnosis of patients' inflammation and other related diseases

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