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Architect 1L86-01

by Abbott Laboratories

Ref 01L8601

Architect 1L86-01 (01L8601) is a device classified as Class A in the EU and Class I in the US made by Abbott Laboratories, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 038074DAL0010FP) and listed in FDA GUDID since 6 Jun 2016 (UDI-DI 00380740001537), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074DAL0010FP Basic UDI-DI 00380740001537UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740001537 UDI-DI Date6 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074DAL0010FP registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740001537 listed 6 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740001537
  2. Registered EUDAMED 038074DAL0010FP

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  • Withdrawn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
Chemiluminescent immunoassay analyser IVD
Device name
ARCHITECT IA Processing Modules
Model / Ref / Catalog
01L8601, 1L86-01
Primary DI / UDI-DI
00380740001537
Basic UDI-DI
038074DAL0010FP
FDA product code
JJE
EMDN code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
GMDN term
Chemiluminescent immunoassay analyser IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2160
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
01L8601
GUDID
1L86-01
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A 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: Chemiluminescent immunoassay analyser IVD

Similar devices in this category

Other devices filed under AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h).

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Properties

  • Professional testing
  • IVD instrument
  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (21, all answered No)