PZH

Serpina1 Variant Detection System

Product code

PZH

Device name

Serpina1 Variant Detection System

Device class

Class 2

21 CFR

21 CFR 866.5130

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).