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Alb AB8301

by Randox Laboratories, Ltd.

Ref AB8301

Alb AB8301 is a device classified as IVD General (EU), Class II (US) made by Randox Laboratories, Ltd., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-05055273208115), cleared under FDA 510(k) K984494 on 23 Mar 1999 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055273208115), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K984494

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05055273208115 Basic UDI-DI 05055273208115UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055273208115 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK984494 Date23 Mar 1999DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055273208115 registered 27 Oct 2026 Active
  • FDA 510(k) K984494 decided 23 Mar 1999 Active
  • FDA GUDID UDI-DI 05055273208115 listed 16 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K984494
  2. Listed FDA GUDID 05055273208115
  3. Registered EUDAMED B-05055273208115

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Albumin (Alb) EUDAMED
Alb GUDID
Generic name
Albumin IVD, reagent
Model / Ref / Catalog
AB8301
Primary DI / UDI-DI
05055273208115
Basic UDI-DI
B-05055273208115
510(k) Number
FDA product code
CIX
EMDN code
W01010201 Albumin (cc)
GMDN term
Albumin IVD, reagent
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1035
EU registration type
Legacy device (under a directive)
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

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

Related devices

Category: Albumin IVD, reagent

Cleared under the same submission (K984494)

Similar devices in this category

Other devices filed under ALBUMIN (CC).

Other devices from Randox Laboratories, Ltd.

See all devices from Randox Laboratories, Ltd. →

Properties

  • Single use
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)