Neutrophils Gelatinase Associated Lipocalin (One step test for NGAL ) - India CDSCO Medical Device Registration

Neutrophils Gelatinase Associated Lipocalin (One step test for NGAL ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000236_d2341edf6c7d358ccf365457b4628f89_fcf72ed22b7dfb5955853424c119a357. 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

Neutrophils Gelatinase Associated Lipocalin (One step test for NGAL )

UID: IMP/IVD/2020/000236_d2341edf6c7d358ccf365457b4628f89_fcf72ed22b7dfb5955853424c119a357

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 neutrophils gelatinase associated lipocaln (Immunofluorescence Assay) in serum and urine. This test is used as an aid in the early diagnosis of acute kidney injury (Immunofluorescence Assay), risk classification and treatment monitoring