PZHClass II

Serpina1 Variant Detection System

21 CFR 866.5130 / Immunology

PZH is the FDA product code for Serpina1 Variant Detection System, a class II device type, regulated under 21 CFR 866.5130. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 3 510(k) clearances under this code, the most recent dated 2021-05-13, and no recalls.

Classification record

Product code: PZH
Device name: Serpina1 Variant Detection System
FDA 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.
Regulation: 21 CFR 866.5130
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 3
Ingested recalls: 0

Clearances, product code PZH

By decision year

3 clearances under product code PZH with a decision year between 2017 and 2021, 2017 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code PZH by decision year
Year	Clearances
2017	1
2019	1
2021	1

Applicants with the most clearances

Product code PZH

Applicants holding the most 510(k) clearances under product code PZH
Applicant	Clearances
Progenika Biopharma S.A., A Grifols Company	3

Companies listing this code with FDA

Companies whose registered establishments list this code

Progenika Biopharma S.A.

Recent clearances

Product code PZH

Recent recalls

Product code PZH

FDA records show no recalls under product code PZH.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)