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BD MAX™ Vaginal Panel 443712

by Becton, Dickinson and Company

Ref 443712

BD MAX Vaginal Panel 443712 is an in vitro diagnostic device (EU IVDR Class C; FDA Class II) made by Becton, Dickinson and Company, registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI 038290VLGBAWJHC9), cleared under FDA 510(k) K201017 on 18 Oct 2021 and listed in FDA GUDID since 23 Mar 2017 (UDI-DI 00382904437121), 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) K201017

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 Number038290VLGBAWJHC9 Basic UDI-DI 00382904437121UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201017 Date18 Oct 2021DecidedStatusActive
United StatesGUDID listing GUDID Number00382904437121 UDI-DI Date23 Mar 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 038290VLGBAWJHC9 registered 22 Sep 2026 Active
  • FDA 510(k) K201017 decided 18 Oct 2021 Active
  • FDA GUDID UDI-DI 00382904437121 listed 23 Mar 2017 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 00382904437121
  2. Cleared FDA 510(k) K201017
  3. Registered EUDAMED 038290VLGBAWJHC9

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  • Withdrawn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™ Vaginal Panel GUDID
Generic name
Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
443712
Primary DI / UDI-DI
00382904437121
Basic UDI-DI
038290VLGBAWJHC9
510(k) Number
FDA product code
NSU, OOI, OUY, PQA
EMDN code
W0105011699, W0105050310, W0105060402
GMDN term
Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Device class
Class C EUDAMED
Class II GUDID
Regulation number
862.2570, 866.3860, 866.3975
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 II

Device class is stated on each registry's own scale: Class C 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 vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Cleared under the same submission (K201017)

Similar devices in this category

Other devices filed under BACTERIOLOGY - NA REAGENTS - OTHER.

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)