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Difco

by Becton, Dickinson and Company 105 variants

Ref 225571

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 Number038290HHBTINSQ7Q Basic UDI-DI 00382902255710UDI-DIDate17 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00382902255710 UDI-DI Date29 Apr 2016ListedStatusListed 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  • Withdrawn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
Difco EUDAMED
BD Difco™ Salmonella H Antiserum Single Factor z15 GUDID
Generic Name
Multiple Salmonella species antigen IVD, reagent
Device Name
BD Difco™ Salmonella O Antiserum Family
Model / Ref / Catalog
225571
Primary DI / UDI-DI
00382902255710
Basic UDI-DI
038290HHBTINSQ7Q
FDA Product Code
GRM
EMDN Code
W0104080301 Serotyping (e.coli, salmonella, shigella, etc)
GMDN Term
Multiple Salmonella species antigen IVD, reagent
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
866.3550
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 3 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000018910
Authorised representative
Becton Dickinson Ireland Limited IE-AR-000007610

Other devices from Becton, Dickinson and Company

See all devices from Becton, Dickinson and Company →

Properties

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

Other properties (14)

  • Sterile: No
  • Implantable: 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