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A1AT Genotyping Test Reagents

by Progenika Biopharma, S.A. Spain EUDAMEDGUDID

Ref 1292380000, 1292320000, 1292320000/1292380000 Product code PZHEMDN W0106010199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number8437013457Gentest001QK Basic UDI-DIDate4 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08437013457095 UDI-DIDate14 Jul 2023ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
A1AT Genotyping Test Reagents EUDAMED
A1AT Genotyping Test EUDAMEDGUDID
Generic Name
Alpha-1-antitrypsin deficiency IVD, kit, nucleic acid technique (NAT)
Device Name
A1AT Genotyping Test ANALYSIS SOFTWARE
Model / Ref / Catalog
1292380000, 1292320000, 1292320000/1292380000, 48 Tests, 192 Tests
Primary DI / UDI-DI
08437013457095, 08437013457101, 08437013457705
Basic UDI-DI
8437013457Gentest001QK, 8437013457Gentest004QR
Direct Marketing DI
08437013457095
08437013457101
08437013457705
510(k) Number
FDA Product Code
PZH, PTA
EMDN Code
W0106010199, W02050192
GMDN Term
Alpha-1-antitrypsin deficiency IVD, kit, nucleic acid technique (NAT)
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
866.5130, 866.5950
Special Device Type
Software
Market of Registration
Spain
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
1292380000
1292320000
1292320000/1292380000
GUDID
48 Tests
192 Tests
Device ClassEUDAMED
Class C
GUDID
Class II

Manufacturer details

EUDAMED SRN
ES-MF-000001005

Other devices from Progenika Biopharma, S.A.

See all devices from Progenika Biopharma, S.A. →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Reagent YesEUDAMEDNoEUDAMED
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
Other properties (17)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (5)

  • EUDAMED d7083fee-5d56-46f5-a68f-3d282ca2efef 61 fields · synced 24 Oct 2026
  • EUDAMED 08437013457101|8437013457GENTEST001QK 61 fields · synced 17 May 2026
  • EUDAMED 08437013457705|8437013457GENTEST004QR 61 fields · synced 18 May 2026
  • FDA UDI d7a9cfee-8b5f-4712-88ee-d5e5b4bceaa8 36 fields · synced 30 May 2026
  • FDA UDI b40be881-5771-4b9d-b022-69e6eef1c71a 36 fields · synced 30 May 2026