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Bd CTGCTV2 443979

by Becton, Dickinson and Company

Ref 443979

Bd CTGCTV2 443979 is a device classified as Class C in the EU and Class I in the US made by Becton, Dickinson and Company, registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI 038290PHXLCEOJF5), cleared under FDA 510(k) K210585 on 10 May 2022 and listed in FDA GUDID since 8 Jun 2022 (UDI-DI 00382904439798), active as of 26 Oct 2026. One FDA recall is linked to it.

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

CE IVDR 510(k)

Valid until

No date given

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

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210585

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 26 Oct 2026.

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038290PHXLCEOJF5 Basic UDI-DI 00382904439798UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00382904439798 UDI-DI Date8 Jun 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK210585 Date10 May 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 038290PHXLCEOJF5 registered 22 Sep 2026 Active
  • FDA 510(k) K210585 decided 10 May 2022 Active
  • FDA GUDID UDI-DI 00382904439798 listed 8 Jun 2022 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0588-2025 FDA Class II initiated 31 Oct 2024

    BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

Timeline

4 dated events

  1. Cleared FDA 510(k) K210585
  2. Listed FDA GUDID 00382904439798
  3. Recall initiated FDA recalls Z-0588-2025
  4. Registered EUDAMED 038290PHXLCEOJF5

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Bd CTGCTV2
Generic name
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
443979
Primary DI / UDI-DI
00382904439798
Basic UDI-DI
038290PHXLCEOJF5
510(k) Number
FDA product code
MKZ, LSL, OUY, QEP
EMDN code
W0105010117, W0105010203, W0105050310
GMDN term
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Device class
Class C EUDAMED
Class I GUDID
Regulation number
866.3120, 866.3390, 866.3860, 866.3393
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class C
GUDID
Class I

Device class is stated on each registry's own scale: Class C 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: Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Similar devices in this category

Other devices filed under CHLAMYDIA.

Other devices from Becton, Dickinson and Company

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Properties

  • Single use
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)