Skip to content

CDX2 [BC39] ACI3184C

by Biocare Medical, LLC

Ref ACI3184C

CDX2 [BC39] ACI3184C is a device classified as IVD General (EU), Class I (US) made by Biocare Medical, LLC, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-00847627003515) and listed in FDA GUDID since 12 Dec 2022 (UDI-DI 00847627003515), withdrawn as of 7 Nov 2026.

Withdrawn Withdrawn in European Union.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

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/IVDD EUDAMED NumberB-00847627003515 Basic UDI-DI 00847627003515UDI-DIDate28 Oct 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00847627003515 UDI-DI Date12 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00847627003515 registered 28 Oct 2026 Withdrawn
  • FDA GUDID UDI-DI 00847627003515 listed 12 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00847627003515
  2. Registered EUDAMED B-00847627003515

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/IVDD Withdrawn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

Specification

EUDAMED · GUDID

Trade name
CDX2 [BC39]
Generic name
Homeobox protein CDX-2 IVD, antibody
Model / reference
ACI3184C
Primary DI / UDI-DI
00847627003515
Basic UDI-DI
B-00847627003515
FDA product code
NJT
EMDN code
W0102039099 Tumour markers - other
GMDN term
Homeobox protein CDX-2 IVD, antibody
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
864.1860
EU registration type
Legacy device (under a directive)
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: Homeobox protein CDX-2 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)