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Alinity 01R1810

by Abbott Ireland Diagnostics

Ref 01R1810

Alinity 01R1810 is an in vitro diagnostic device (EU IVDR Class C; FDA Class I; FDA product code JJX, Single (specified) analyte controls (assayed and unassayed)) made by Abbott Ireland Diagnostics, registered in EUDAMED on 19 Aug 2026 (Basic UDI-DI 038074AIR0118L3) and listed in FDA GUDID since 4 Jan 2019 (UDI-DI 00380740153946), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074AIR0118L3 Basic UDI-DI 00380740153946UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740153946 UDI-DI Date4 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074AIR0118L3 registered 19 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740153946 listed 4 Jan 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740153946
  2. Registered EUDAMED 038074AIR0118L3

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  • Withdrawn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
Procalcitonin (PCT) IVD, control
Device name
Alinity i B-R-A-H-M-S PCT
Model / Ref / Catalog
01R1810
Primary DI / UDI-DI
00380740153946
Basic UDI-DI
038074AIR0118L3
FDA product code
JJX
EMDN code
W0102152008 Controls for individual and specific hormones
GMDN term
Procalcitonin (PCT) IVD, control
Device class
Class C EUDAMED
Class I GUDID
Regulation number
862.1660
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class C
GUDID
Class I

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

Related devices

Category: Procalcitonin (PCT) IVD, control

Similar devices in this category

Other devices filed under CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES.

Other devices from Abbott Ireland Diagnostics

See all devices from Abbott Ireland Diagnostics →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (15, all answered No)