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CD1a [O10] API3158AA

by Biocare Medical, LLC

Ref API3158AA

CD1a [O10] API3158AA is a device classified as IVD General (EU), Class I (US) made by Biocare Medical, LLC, registered in EUDAMED on 25 Aug 2026 (Basic UDI-DI B-00847627004444) and listed in FDA GUDID since 7 Dec 2022 (UDI-DI 00847627004444), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00847627004444 Basic UDI-DI 00847627004444UDI-DIDate25 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00847627004444 UDI-DI Date7 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00847627004444 registered 25 Aug 2026 Active
  • FDA GUDID UDI-DI 00847627004444 listed 7 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00847627004444
  2. Registered EUDAMED B-00847627004444

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  • Withdrawn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
CD1a [O10]
Generic name
CD1a cell marker IVD, antibody
Model / reference
API3158AA
Primary DI / UDI-DI
00847627004444
Basic UDI-DI
B-00847627004444
FDA product code
NJT
EMDN code
W0102039099 Tumour markers - other
GMDN term
CD1a cell marker IVD, antibody
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
864.1860
EU registration type
Legacy device (under a directive)
EU market of registration
Bulgaria
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: CD1a cell marker IVD, antibody

Similar devices in this category

Other devices filed under TUMOUR MARKERS - OTHER.

Other devices from Biocare Medical, LLC

See all devices from Biocare Medical, LLC →

Properties

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