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Alinity 09P3810

by Abbott

Ref 09P3810

Alinity 09P3810 is an in vitro diagnostic device (EU IVDR Class B; FDA Class I; FDA product code JJX, Single (specified) analyte controls (assayed and unassayed)) made by Abbott, registered in EUDAMED on 23 Aug 2026 (Basic UDI-DI 038074AIP0938LT) and listed in FDA GUDID since 12 Jul 2018 (UDI-DI 00380740151386), 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 Number038074AIP0938LT Basic UDI-DI 00380740151386UDI-DIDate23 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740151386 UDI-DI Date12 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074AIP0938LT registered 23 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740151386 listed 12 Jul 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740151386
  2. Registered EUDAMED 038074AIP0938LT

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  • Withdrawn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
Sex hormone binding globulin (SHBG) IVD, control
Device name
Alinity i SHBG
Model / Ref / Catalog
09P3810
Primary DI / UDI-DI
00380740151386
Basic UDI-DI
038074AIP0938LT
FDA product code
JJX
EMDN code
W0102152003 Specific protein controls
GMDN term
Sex hormone binding globulin (SHBG) IVD, control
Device class
Class B 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 B
GUDID
Class I

Device class is stated on each registry's own scale: Class B 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: Sex hormone binding globulin (SHBG) IVD, control

Similar devices in this category

Other devices filed under SPECIFIC PROTEIN CONTROLS.

Other devices from Abbott

See all devices from Abbott →

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)