Skip to content

Architect 1P36-01

by Abbott

Ref 01P3601

Architect 1P36-01 (01P3601) is a carbamazepine therapeutic drug monitoring IVD (EU IVDR Class C; FDA Class II) made by Abbott, registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 038074ARP0136P4), cleared under FDA 510(k) K103627 on 14 Oct 2011 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00380740001834), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K103627

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074ARP0136P4 Basic UDI-DI 00380740001834UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740001834 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK103627 Date14 Oct 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 038074ARP0136P4 registered 24 Aug 2026 Active
  • FDA 510(k) K103627 decided 14 Oct 2011 Active
  • FDA GUDID UDI-DI 00380740001834 listed 9 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K103627
  2. Listed FDA GUDID 00380740001834
  3. Registered EUDAMED 038074ARP0136P4

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  • Withdrawn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
Architect
Generic name
Carbamazepine therapeutic drug monitoring IVD, calibrator
Device name
Architect iCarbamazepine
Model / Ref / Catalog
01P3601, 1P36-01
Primary DI / UDI-DI
00380740001834
Basic UDI-DI
038074ARP0136P4
510(k) Number
FDA product code
DKB, KLT
EMDN code
W0102152201 Tdm/drug standards and calibrators
GMDN term
Carbamazepine therapeutic drug monitoring IVD, calibrator
Device class
Class C EUDAMED
Class II GUDID
Regulation number
862.3200, 862.3645
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
01P3601
GUDID
1P36-01
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: Carbamazepine therapeutic drug monitoring IVD, calibrator

Cleared under the same submission (K103627)

Similar devices in this category

Other devices filed under TDM/DRUG STANDARDS AND CALIBRATORS.

Other devices from Abbott

See all devices from Abbott →

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)