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Architect 6E57-03

by Abbott

Ref 06E5703Model 6E57-03

Architect 6E57-03 (06E5703) is an in vitro diagnostic device (EU IVDD general IVD; FDA Class II; FDA product code JIT, Calibrator, secondary) made by Abbott, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-00380740175429) and listed in FDA GUDID since 23 May 2020 (UDI-DI 00380740175429), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00380740175429 Basic UDI-DI 00380740175429UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740175429 UDI-DI Date23 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740175429 registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740175429 listed 23 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740175429
  2. Registered EUDAMED B-00380740175429

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  • Withdrawn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
Architect
Generic name
Prealbumin (transthyretin) IVD, calibrator
Model / Ref / Catalog
6E57-03, 06E5703
Primary DI / UDI-DI
00380740175429
Basic UDI-DI
B-00380740175429
FDA product code
JIT
EMDN code
W0102152203 Specific protein standards and calibrators
GMDN term
Prealbumin (transthyretin) IVD, calibrator
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1150
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
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: Prealbumin (transthyretin) IVD, calibrator

Similar devices in this category

Other devices filed under SPECIFIC PROTEIN STANDARDS AND CALIBRATORS.

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Properties

  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)