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BD MAX™ Enteric Bacterial Panel 442963

by Becton, Dickinson and Company

Ref 442963

BD MAX Enteric Bacterial Panel 442963 is an in vitro diagnostic device (EU IVDR Class B; FDA Class II) made by Becton, Dickinson and Company, registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI 038290LPFYAPPWGC), cleared under FDA 510(k) K214122 on 28 Jul 2022 and listed in FDA GUDID since 17 Oct 2016 (UDI-DI 00382904429638), active as of 26 Oct 2026.

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

None found

in data synced 26 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K214122

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 Number038290LPFYAPPWGC Basic UDI-DI 00382904429638UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK214122 Date28 Jul 2022DecidedStatusActive
United StatesGUDID listing GUDID Number00382904429638 UDI-DI Date17 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 038290LPFYAPPWGC registered 13 Oct 2026 Active
  • FDA 510(k) K214122 decided 28 Jul 2022 Active
  • FDA GUDID UDI-DI 00382904429638 listed 17 Oct 2016 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 00382904429638
  2. Cleared FDA 510(k) K214122
  3. Registered EUDAMED 038290LPFYAPPWGC

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  • Withdrawn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
Max EUDAMED
BD MAX™ Enteric Bacterial Panel GUDID
Generic name
Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
442963
Primary DI / UDI-DI
00382904429638
Basic UDI-DI
038290LPFYAPPWGC
510(k) Number
FDA product code
PCH, OOI, PCI
EMDN code
W0105011003, W0105011402, W0105011503, W0105011614
GMDN term
Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Device class
Class B EUDAMED
Class II GUDID
Regulation number
866.3990, 862.2570
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 B
GUDID
Class II

Device class is stated on each registry's own scale: Class B 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: Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

Cleared under the same submission (K214122)

Similar devices in this category

Other devices filed under SALMONELLA DETECTION BY NA REAGENTS.

Other devices from Becton, Dickinson and Company

See all devices from Becton, Dickinson and Company →

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)