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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device serpina1 variant detection system
Regulation Description Alpha-1-antitrypsin immunological test system.
Definition This is a qualitative DNA detection in vitro diagnostic test to be used in conjunction with a visualization instrument and its software. This test is for the simultaneous detection and identification of allelic variants found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. This assessment system provides users with genetic information regarding genotypes of SERPINA1 allelic variants and is intended to be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of individuals with A1AT deficiency.
Product CodePZH
Regulation Number 866.5130
Device Class 2