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Ast AS3804

by Randox Laboratories, Ltd.

Ref AS3804

Ast AS3804 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-05055273200478), cleared under FDA 510(k) K923505 on 16 Nov 1992 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 05055273200478), 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) K923505

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-05055273200478 Basic UDI-DI 05055273200478UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055273200478 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK923505 Date16 Nov 1992DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055273200478 registered 27 Oct 2026 Active
  • FDA 510(k) K923505 decided 16 Nov 1992 Active
  • FDA GUDID UDI-DI 05055273200478 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

3 dated events

  1. Cleared FDA 510(k) K923505
  2. Listed FDA GUDID 05055273200478
  3. Registered EUDAMED B-05055273200478

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  • Withdrawn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
Aspartate Aminotransferase (Ast) EUDAMED
Ast GUDID
Generic name
Aspartate aminotransferase (AST) isoenzyme IVD, reagent
Model / Ref / Catalog
AS3804
Primary DI / UDI-DI
05055273200478
Basic UDI-DI
B-05055273200478
510(k) Number
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

Cleared under the same submission (K923505)

and 3 more cleared under K923505

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)