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Alt AL3801

by Randox Laboratories, Ltd.

Ref AL3801

Alt AL3801 is a device classified as IVD General (EU), Class I (US) made by Randox Laboratories, Ltd., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-05055273200218), cleared under FDA 510(k) K923510 on 16 Nov 1992 and listed in FDA GUDID since 21 Dec 2018 (UDI-DI 05055273200218), 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) K923510

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-05055273200218 Basic UDI-DI 05055273200218UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055273200218 UDI-DI Date21 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK923510 Date16 Nov 1992DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055273200218 registered 27 Oct 2026 Active
  • FDA 510(k) K923510 decided 16 Nov 1992 Active
  • FDA GUDID UDI-DI 05055273200218 listed 21 Dec 2018 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) K923510
  2. Listed FDA GUDID 05055273200218
  3. Registered EUDAMED B-05055273200218

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  • Withdrawn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
Alanine Aminotransferase (Alt) EUDAMED
Alt GUDID
Generic name
Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
Model / Ref / Catalog
AL3801
Primary DI / UDI-DI
05055273200218
Basic UDI-DI
B-05055273200218
510(k) Number
FDA product code
CKA
EMDN code
W01010103 Alanine amino-transferase
GMDN term
Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1030
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 I

Device class is stated on each registry's own scale: Class IVD General 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: Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

Cleared under the same submission (K923510)

and 4 more cleared under K923510

Similar devices in this category

Other devices filed under ALANINE 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)