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Bbl

by Becton, Dickinson and Company United States EUDAMEDGUDID

Ref 240924

Product code GTZEMDN W0105011199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038290QRQTLGKVPL Basic UDI-DIDate26 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00382902409243 UDI-DIDate25 May 2018ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Bbl EUDAMED
BD BBL ™ Streptocard™ Enzyme Extraction GUDID
Generic Name
Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination
Device Name
BD BBL™ Streptocard™ Enzyme Extraction
Model / Ref / Catalog
240924
Primary DI / UDI-DI
00382902409243
Basic UDI-DI
038290QRQTLGKVPL
FDA Product Code
GTZ
EMDN Code
W0105011199 Streptococcal reagents - other
GMDN Term
Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination
Device Class
Class B EUDAMED
Class I GUDID
Regulation Number
866.3740
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution
Size
Total Volume — 22.0 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class I

Manufacturer details

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

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED 1e47a403-89c0-40b1-b05f-c9ca58b4cbcd 61 fields · synced 24 Oct 2026
  • FDA UDI 2a750fa5-3fd5-4958-b882-691c38c408e1 37 fields · synced 30 May 2026