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BD Phoenix™ YEAST ID 448316

by Becton, Dickinson and Company

Ref 448316

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038290JHJJQPLUAD Basic UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00382904483166 UDI-DIDate25 May 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Phoenix EUDAMED
BD Phoenix™ YEAST ID GUDID
Generic Name
Yeast species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Model / Ref / Catalog
448316
Primary DI / UDI-DI
00382904483166
Basic UDI-DI
038290JHJJQPLUAD
FDA Product Code
JXB
EMDN Code
W0104030403 Identification systems for yeasts and fungi - automated
GMDN Term
Yeast species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Device Class
Class B EUDAMED
Class I GUDID
Regulation Number
866.2660
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 I

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Properties

  • Single Use
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (15)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No