Skip to content

AIX1000 Analyzer 00400R

by Gold Standard Diagnostics, LLC

Ref 00400RModel AIX1000 Analyzer

AIX1000 Analyzer 00400R is a device classified as Class A in the EU and Class II in the US made by Gold Standard Diagnostics, LLC, registered in EUDAMED on 13 Jul 2026 (Basic UDI-DI ++B35000400RX4), cleared under FDA 510(k) K250249 on 10 Oct 2025 (1 earlier submission) and listed in FDA GUDID since 31 Oct 2023 (UDI-DI B35000400R0), active as of 24 Oct 2026.

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

CE IVDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250249

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number++B35000400RX4 Basic UDI-DI B35000400R0UDI-DIDate13 Jul 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK250249 Date10 Oct 2025DecidedStatusActive
United StatesGUDID listing GUDID NumberB35000400R0 UDI-DI Date31 Oct 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++B35000400RX4 registered 13 Jul 2026 Active
  • FDA 510(k) K250249 decided 10 Oct 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI B35000400R0 listed 31 Oct 2023 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K150358
  2. Listed FDA GUDID B35000400R0
  3. Cleared FDA 510(k) K250249
  4. Registered EUDAMED ++B35000400RX4

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
AIX1000 Analyzer
Generic name
Agglutination assay digital imaging reader/analyser IVD
Model / Ref / Catalog
00400R, AIX1000 Analyzer
Primary DI / UDI-DI
B35000400R0
Basic UDI-DI
++B35000400RX4
510(k) Number
FDA product code
GMQ
EMDN code
W0204 Infectious immunology instruments
GMDN term
Agglutination assay digital imaging reader/analyser IVD
Device class
Class A EUDAMED
Class II GUDID
Regulation number
866.3820
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 A
GUDID
Class II

Device class is stated on each registry's own scale: Class A 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: Treponema pallidum reagin antibody IVD, kit, agglutinationAgglutination assay digital imaging reader/analyser IVD

Cleared under the same submission (K150358)

and 1 more cleared under K150358

Cleared under the same submission (K250249)

Similar devices in this category

Other devices filed under INFECTIOUS IMMUNOLOGY INSTRUMENTS.

Other devices from Gold Standard Diagnostics, LLC

See all devices from Gold Standard Diagnostics, LLC →

Properties

  • Professional testing
  • IVD instrument
  • Prescription use
  • Serial number
Other properties (22, all answered No)