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CT0033B

by Oxoid Limited

Ref CT0033B

CT0033B is a device classified as IVD General (EU), Class II (US) made by Oxoid Limited, registered in EUDAMED on 25 Aug 2026 (Basic UDI-DI B-05032384005789), cleared under FDA 510(k) K860153 on 4 Mar 1986 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05032384005789), active as of 22 Oct 2026. 6 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

6 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K860153

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05032384005789 Basic UDI-DI 05032384005789UDI-DIDate25 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05032384005789 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK860153 Date4 Mar 1986DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05032384005789 registered 25 Aug 2026 Active
  • FDA 510(k) K860153 decided 4 Mar 1986 Active
  • FDA GUDID UDI-DI 05032384005789 listed 24 Sep 2016 Listed

Recalls

6 recalls · FDA

    • Terminated Z-0443-2016 FDA Class II initiated 6 Nov 2015

    Antibiotic concentration may be insufficient which may result in incorrect test results.

    • Terminated Z-1246-2014 FDA Class II initiated 18 Feb 2014

    Some of the discs may not be impregnated with the antibiotic.

    • Terminated Z-0794-2014 FDA Class II initiated 9 Apr 2013

    Cartridges may contain individual discs which were not impregnated with antibiotic.

    • Terminated Z-2081-2013 FDA Class III initiated 25 Mar 2013

    Use of affected lots may give false indication of susceptibility to Nitrofurantoin.

    • Terminated Z-0528-2014 FDA Class III initiated 21 Nov 2012

    Boxes labeled as CIP5 may contain cartridges of AMP5.

    • Terminated Z-0808-2013 FDA Class II initiated 21 Aug 2012

    The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.

Timeline

9 dated events

  1. Cleared FDA 510(k) K860153
  2. Recall initiated FDA recalls Z-0808-2013
  3. Recall initiated FDA recalls Z-0528-2014
  4. Recall initiated FDA recalls Z-2081-2013
  5. Recall initiated FDA recalls Z-0794-2014
  6. Recall initiated FDA recalls Z-1246-2014
  7. Recall initiated FDA recalls Z-0443-2016
  8. Listed FDA GUDID 05032384005789
  9. Registered EUDAMED B-05032384005789

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Neomycin
Generic name
Neomycin sulfate susceptibility testing disc IVD
Model / reference
CT0033B
Primary DI / UDI-DI
05032384005789
Basic UDI-DI
B-05032384005789
510(k) Number
FDA product code
JTN
EMDN code
W0104080502 Impregnated disks, multi-disks & tablets
GMDN term
Neomycin sulfate susceptibility testing disc IVD
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
866.1620
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Neomycin sulfate susceptibility testing disc IVD

Cleared under the same submission (K860153)

and 7 more cleared under K860153

Similar devices in this category

Other devices filed under IMPREGNATED DISKS, MULTI-DISKS & TABLETS.

Other devices from Oxoid Limited

See all devices from Oxoid Limited →

Properties

  • Contains substances of microbial origin
  • Reagent
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)