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Architect 06P2201

by Abbott

Ref 06P2201

Architect 06P2201 is a device classified as IVD General (EU), Class I (US) made by Abbott, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-00380740138905) and listed in FDA GUDID since 16 Aug 2017 (UDI-DI 00380740138905), 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-00380740138905 Basic UDI-DI 00380740138905UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740138905 UDI-DI Date16 Aug 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740138905 registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740138905 listed 16 Aug 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740138905
  2. Registered EUDAMED B-00380740138905

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  • Withdrawn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
Procalcitonin (PCT) IVD, calibrator
Device name
Brahms Pct
Model / Ref / Catalog
06P2201
Primary DI / UDI-DI
00380740138905
Basic UDI-DI
B-00380740138905
FDA product code
JJX, PMT, PRI, PTF, JIT
EMDN code
W0102152008 Controls for individual and specific hormones
GMDN term
Procalcitonin (PCT) IVD, calibrator
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1660, 866.3215, 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 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: Procalcitonin (PCT) IVD, calibrator

Similar devices in this category

Other devices filed under CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES.

Other devices from Abbott

See all devices from Abbott →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)