H-FABP - India CDSCO Medical Device Registration
H-FABP is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000039_7b01fd33007077ca29dd4ed98e16c996_de396a2de1bbab5f4d56dc4887db1587. This device is marketed under the brand name PCT Rapid Quantitative Test. The license holder is M/s Avantor Performance Materials India Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
PCT Rapid Quantitative Test
License Holder
M/s Avantor Performance Materials India LtdDevice Class
Approving Authority
CDSCO
Product Information
Quantitative determination of H-FABP in human whole blood, serum or plasma. This test is used as an aid to assist in the diagnosis of myocardial infarction
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