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Architect 1P34-01

by Abbott Laboratories

Ref 01P3401

Architect 1P34-01 (01P3401) is a phenytoin therapeutic drug monitoring IVD (EU IVDR Class C; FDA Class II) made by Abbott Laboratories, registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI 038074ARP0134NY) and listed in FDA GUDID since 6 Jun 2016 (UDI-DI 00380740001797), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074ARP0134NY Basic UDI-DI 00380740001797UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740001797 UDI-DI Date6 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ARP0134NY registered 15 Jul 2026 Active
  • FDA GUDID UDI-DI 00380740001797 listed 6 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740001797
  2. Registered EUDAMED 038074ARP0134NY

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Architect
Generic name
Phenytoin therapeutic drug monitoring IVD, calibrator
Device name
ARCHITECT iPhenytoin
Model / Ref / Catalog
01P3401, 1P34-01
Primary DI / UDI-DI
00380740001797
Basic UDI-DI
038074ARP0134NY
FDA product code
DIP, LGR
EMDN code
W0102152201 Tdm/drug standards and calibrators
GMDN term
Phenytoin therapeutic drug monitoring IVD, calibrator
Device class
Class C EUDAMED
Class II GUDID
Regulation number
862.3350
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
01P3401
GUDID
1P34-01
Device classEUDAMED
Class C
GUDID
Class II

Device class is stated on each registry's own scale: Class C 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: Phenytoin therapeutic drug monitoring IVD, calibrator

Similar devices in this category

Other devices filed under TDM/DRUG STANDARDS AND CALIBRATORS.

Other devices from Abbott Laboratories

See all devices from Abbott Laboratories →

Properties

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