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BD BACTEC™ Myco/F Lytic Culture Vials 442794

by Becton, Dickinson and Company

Ref 442794

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 26 Oct 2026

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 Number038290PLDTDYRJFH Basic UDI-DI 30382904427949UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30382904427949 UDI-DI Date13 Jun 2023ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 Oct 2026.

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  • Withdrawn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
Bactec EUDAMED
BD BACTEC™ Myco/F Lytic Culture Vials GUDID
Generic Name
Culture medium antimicrobial supplement IVD
Model / Ref / Catalog
442794
Primary DI / UDI-DI
30382904427949
Basic UDI-DI
038290PLDTDYRJFH
Unit of Use DI
00382904427948
510(k) Number
FDA Product Code
MDB
EMDN Code
W0104010603 Automated mycobacteria media (bottles)
GMDN Term
Culture medium antimicrobial supplement IVD
Device Class
Class C EUDAMED
Class I GUDID
Regulation Number
866.2560
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 40 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class C
GUDID
Class I

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Properties

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

Other properties (15)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No