PZH · Class II · 21 CFR 866.5130

FDA Product Code PZH: Serpina1 Variant Detection System

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.

Leading manufacturers include Progenika Biopharma S.A., A Grifols Company.

3
Total
3
Cleared
68d
Avg days
2017
Since

FDA 510(k) Cleared Serpina1 Variant Detection System Devices (Product Code PZH)

3 devices
1–3 of 3
Cleared May 13, 2021
A1AT Genotyping Test
K211115
Progenika Biopharma S.A., A Grifols Company
Immunology · 29d

About Product Code PZH - Regulatory Context

PZH devices are reviewed by the Immunology panel. Browse all Immunology devices →