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Architect 2P13-01

by Abbott

Part of a family of 7 devices: see the family page

Ref 02P1301

Architect 2P13-01 (02P1301) is a device classified as Class B in the EU and Class I in the US made by Abbott, registered in EUDAMED on 19 Aug 2026 (Basic UDI-DI 038074ARP0213NV) and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00380740003708), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074ARP0213NV Basic UDI-DI 00380740003708UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740003708 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ARP0213NV registered 19 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740003708 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740003708
  2. Registered EUDAMED 038074ARP0213NV

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  • Withdrawn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
Total testosterone IVD, calibrator
Model / Ref / Catalog
02P1301, 2P13-01
Primary DI / UDI-DI
00380740003708
Basic UDI-DI
038074ARP0213NV
FDA product code
JJX, JIT, CDZ
EMDN code
W0102152202 Hormone standards and calibrators
GMDN term
Total testosterone IVD, calibrator
Device class
Class B EUDAMED
Class I GUDID
Regulation number
862.1660, 862.1150, 862.1680
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
02P1301
GUDID
2P13-01
Device classEUDAMED
Class B
GUDID
Class I

Device class is stated on each registry's own scale: Class B 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: Total testosterone IVD, calibrator

Similar devices in this category

Other devices filed under HORMONE STANDARDS AND CALIBRATORS.

Other devices from Abbott

See all devices from Abbott →

Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)