(MicroMGIT) OADC ENRICHMENT, 6 vials, kit [BD-245116]

STD ELAEFLUC303

Valid Article

Former Code(s): SLASOADC1--
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
18
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W02039085 - Various microbiology instruments - consumables
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
The order of this product needs to be justified and is only acceptable under certain conditions.
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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(MicroMGIT) OADC ENRICHMENT

Reserved for TB culture programmes.

Definition

Enrichment for MGIT broth tubes for the isolation and cultivation of Mycobacteria. It is mandatory for BBL MGIT manual system.

Specifications

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Technical specifications

  • Liquid, highly viscous
  • Composition: Bovine albumine, Dextrose, Catalase, Oleic acid

Packaging & Labelling

6 vials of 15 ml

Transport not regulated

Instructions for use

Each vial is sufficient to supplement:

  • 25 BBL MGIT 4 ml tubes (manual system)
  • 18 MGIT 7 ml tubes (BACTEC MGIT automated system)

Do not open until ready to use.

Just prior sample inoculation, unscrew the MGIT broth tubes and aseptically add volume of MGIT OADC‌ according to Standard Operational Procedures.

Storage

  • Keep refrigerated between 2º C and 8º C
  • Store in the dark, away from oxidizing agents
  • Avoid freezing or overheating
  • Minimize exposure to light
  • Shelf life: 18 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

(Cf Introduction: Thermosensitive products)

MSF requirements

  • Mandatory for enrichment of BBL MGIT 4 ml tubes before sample inoculation. Used on MGIT manual system.
  • It is also used to enrich MGIT 7 ml tubes to perform second line drug susceptibility testing with the BACTEC MGIT automated system.
  • Do not confuse with BBL Middlebrook OADC Enrichment (code: 211886).
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