Skip to content

CitoCBC Control 1310

by Cytochip, Inc.

Ref 1310

CitoCBC Control 1310 is a device classified as IVD General made by Cytochip, Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00850063751315) and listed in FDA GUDID since 1 Jul 2025 (UDI-DI 00850063751315), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00850063751315 Basic UDI-DI 00850063751315UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850063751315 UDI-DI Date1 Jul 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00850063751315 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00850063751315 listed 1 Jul 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850063751315
  2. Registered EUDAMED B-00850063751315

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  • Withdrawn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
CitoCBC Control
Generic name
Full blood count IVD, control
Model / reference
1310
Primary DI / UDI-DI
00850063751315
Basic UDI-DI
B-00850063751315
EMDN code
W0103010503 Multilevel blood controls
GMDN term
Full blood count IVD, control
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Related devices

Category: Full blood count IVD, control

Similar devices in this category

Other devices filed under MULTILEVEL BLOOD CONTROLS.

Other devices from Cytochip, Inc.

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Near-patient testing
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (14, all answered No)