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Ast AS8306

by Randox Laboratories, Ltd.

Ref AS8306

Ast AS8306 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-05055273208245) and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 05055273208245), active as of 7 Nov 2026.

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

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05055273208245 Basic UDI-DI 05055273208245UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055273208245 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05055273208245 registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 05055273208245 listed 9 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 05055273208245
  2. Registered EUDAMED B-05055273208245

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Aspartate Aminotransferase (Ast) EUDAMED
Ast GUDID
Generic name
Aspartate aminotransferase (AST) isoenzyme IVD, reagent
Model / Ref / Catalog
AS8306
Primary DI / UDI-DI
05055273208245
Basic UDI-DI
B-05055273208245
FDA product code
CIT
EMDN code
W01010110 Aspartate amino-transferase
GMDN term
Aspartate aminotransferase (AST) isoenzyme IVD, reagent
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1100
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: Aspartate aminotransferase (AST) isoenzyme IVD, reagent

Similar devices in this category

Other devices filed under ASPARTATE AMINO-TRANSFERASE.

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)