Microalbuminuria (One step test for mAlb ) - India CDSCO Medical Device Registration

Microalbuminuria (One step test for mAlb ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000236_7fe914d29a73a1a452f37f89f98603fc_8e73de3e988598aa2cb6d509ed24cca2. This device is marketed under the brand name Immunofluorescence Assay. The license holder is Cosmic Scientific Technologies, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Microalbuminuria (One step test for mAlb )

UID: IMP/IVD/2020/000236_7fe914d29a73a1a452f37f89f98603fc_8e73de3e988598aa2cb6d509ed24cca2

Brand Name

Immunofluorescence Assay

License Holder

Cosmic Scientific Technologies

Device Class

Class B

Approving Authority

CDSCO

Product Information

One step test for mAlb (Immunofluorescence Assay) is intended for in vitro quantitative determination of microalbuminuria (Immunofluorescence Assay) in urine . An elevated mAlb concentration below below the proteinuric level has long been recognized as a marker of kidney and increased cardiovascular risk in diabetic nephropathy