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Heart-type Fatty Acid-binding Protein (Heart-type Fatty Acid-binding Protein ) - India CDSCO Medical Device Registration

Heart-type Fatty Acid-binding Protein (Heart-type Fatty Acid-binding Protein ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000104_77b779ef55f2117bc5139622ca6e883f_5ea64b79787a7ea262443aa104395de3. This device is marketed under the brand name CLIA. The license holder is M/s. Peerless Biotech Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Heart-type Fatty Acid-binding Protein (Heart-type Fatty Acid-binding Protein )
UID: IMP/IVD/2023/000104_77b779ef55f2117bc5139622ca6e883f_5ea64b79787a7ea262443aa104395de3

Brand Name

CLIA

Device Class

Class C

Approving Authority

CDSCO

Product Information

Heart-type Fatty Acid-binding Protein (CLIA) is a Chemiluminescence Immunoassay (CLIA) test for the quantitative measurement of circulating Heart-type Fatty Acid-binding Protein (CLIA) in human serum, plasma and whole blood, which is intended as an aid to diagnosis of acute myocardial Infarction. The assay can be used for samples over the range of 0.5ng/mL~160ng/mL

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