Product code PZH

Device name

Serpina1 Variant Detection System

Medical specialty

Immunology

Device class

2

Regulation number

866.5130

Review panel

IM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset