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Alinity 07P9201

by Abbott Ireland Diagnostics

Part of a family of 7 devices: see the family page

Ref 07P9201

Alinity 07P9201 is a device classified as Class C in the EU and Class III in the US made by Abbott Ireland Diagnostics, registered in EUDAMED on 19 Aug 2026 (Basic UDI-DI 038074AIP0792LP) and listed in FDA GUDID since 18 Nov 2020 (UDI-DI 00380740130411), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074AIP0792LP Basic UDI-DI 00380740130411UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740130411 UDI-DI Date18 Nov 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074AIP0792LP registered 19 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740130411 listed 18 Nov 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740130411
  2. Registered EUDAMED 038074AIP0792LP

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Alinity
Generic name
Total prostate specific antigen (tPSA) IVD, calibrator
Device name
Alinity i Total PSA
Model / Ref / Catalog
07P9201
Primary DI / UDI-DI
00380740130411
Basic UDI-DI
038074AIP0792LP
FDA product code
MTF
EMDN code
W0102152205 Tumour marker standards and calibrators
GMDN term
Total prostate specific antigen (tPSA) IVD, calibrator
Device class
Class C EUDAMED
Class III GUDID
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class C
GUDID
Class III

Device class is stated on each registry's own scale: Class C in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Total prostate specific antigen (tPSA) IVD, calibrator

Similar devices in this category

Other devices filed under TUMOUR MARKER STANDARDS AND CALIBRATORS.

Other devices from Abbott Ireland Diagnostics

See all devices from Abbott Ireland Diagnostics →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)