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BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes 245122

by Becton, Dickinson and Company EUDAMEDGUDID

Active European Union

Ref 245122

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038290WACOWYGQF9 Basic UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00382902451228 UDI-DIDate7 Jan 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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

2 recalls · FDA

    • Terminated Z-0028-2014 FDA Class II initiated 9 Sep 2013

    An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result.

    • Terminated Z-2890-2011 FDA Unclassified (pre-2012) initiated 28 Mar 2011

    Software contained three additional set configurations which caused the system to reinitialized the AST set carrier defaults.

Specification

EUDAMED · GUDID

Trade Name
Bactec Mgit EUDAMED
BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes GUDID
Generic Name
Differential/selective broth culture medium IVD
Device Name
BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes, 7 mL
Model / Ref / Catalog
245122
Primary DI / UDI-DI
00382902451228
Basic UDI-DI
038290WACOWYGQF9
510(k) Number
FDA Product Code
MDB
EMDN Code
W0104010603 Automated mycobacteria media (bottles)
GMDN Term
Differential/selective broth culture medium IVD
Device Class
Class C EUDAMED
Class I GUDID
Regulation Number
866.2560
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 7 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class C
GUDID
Class I

Related devices

Cleared under the same submission (K974883)

Other devices from Becton, Dickinson and Company

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Properties

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

Other properties (16)

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