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MSH6 OPAI265T60

by Biocare Medical, LLC

Ref OPAI265T60Model MSH6

MSH6 OPAI265T60 is a device classified as IVD General (EU), Class I (US) made by Biocare Medical, LLC, registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI B-00847627024961) and listed in FDA GUDID since 23 Sep 2022 (UDI-DI 00847627024961), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00847627024961 Basic UDI-DI 00847627024961UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00847627024961 UDI-DI Date23 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00847627024961 registered 25 Sep 2026 Active
  • FDA GUDID UDI-DI 00847627024961 listed 23 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00847627024961
  2. Registered EUDAMED B-00847627024961

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  • Withdrawn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
MSH6
Generic name
MSH6 antigen IVD, antibody
Device name
OPAI265T60
Model / reference
OPAI265T60, MSH6
Primary DI / UDI-DI
00847627024961
Basic UDI-DI
B-00847627024961
FDA product code
NJT
EMDN code
W01060214 Colorectal cancer (msi-h / dmmr)
GMDN term
MSH6 antigen 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
Italy
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: MSH6 antigen IVD, antibody

Similar devices in this category

Other devices filed under COLORECTAL CANCER (MSI-H / DMMR).

Other devices from Biocare Medical, LLC

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Properties

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