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(MicroMGIT) CULTURE TUBES, 4 ml, pack [BD-245111]

https://unicat.msf.org/cat/product/18815
STD ELAEFLUC306

Valid Article

Former Code(s): SLASMGIT4--
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).
12
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.
P
The order of this product needs to be justified and is only acceptable under certain conditions.
CT25
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) CULTURE TUBE, 4 ml, manual system

Reserved for TB culture programmes.

Definition

Tube prefilled with mycobacteria growth indicator and additonal 4 ml of Middlebrook 7H9 broth base, used for detection and recovery of mycobacteria from clinical specimens and body fluids (except urine and blood) with MGIT Manual System Method. The tubes are also used for drug susceptibility testing.

MGIT Mycobacteria Growth Indicator Tube Technique.

At the bottom of the MGIT tube includes a fluorescent compound in silicone, sensitive to the presence of oxygen dissolved in the broth contained in the tube. Initially the high quantity of oxygen present inhibits emission of fluorescence of the compound and only little fluorescence can be observed. Growth of microorganisms will consume the oxygen and fluorescence will be observed using a 365 nm UV light. Growth will also be observed by the presence of turbidity, or small grains, in the tube.

Specifications

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Components

  • Plastic tube, 4 ml
  • Screw-top
  • The Mycobacteria Growth Indicator Tube contains: 110 µL of fluorescent indicator and 4 mL of broth. The indicator contains Tris 4, 7-diphenyl-1,10-phenanthroline ruthenium chloride pentahydrate in a silicone rubber base. The tubes are flushed with 10% CO2 and capped with polypropylene caps.
  • Approximate Formula* Per L Purified Water:
    • Modified Middlebrook 7H9 Broth Base.................5.9 g
    • Casein peptone ....................................................1.25 g

Packaging & Labelling

  • 25 or 100 x 4 ml tubes
  • Transport not regulated

Instructions for use

  • Read carefully the packaging insert before first use, and follow carefully the instructions.
  • The 4 ml tubes are only to be used for the MGIT manual system.
  • Do not use if turbid

Storage

  • Store the tube between +2ºC and +25°C
  • Do not freeze
  • Minimize exposure to light. Broth of unused tubes should appear clear and colourless
  • Keep away from oxidizing substances
  • Shelf life: 12 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

(Cf Introduction: Thermosensitive products)

MSF requirements

MGIT Manual System Technique allows rapid recovery of Mycobacteria on liquid medium, shortening of 1-2 weeks the detection time expected with Lowenstein–Jensen egg based solid medium. The system is also used for susceptibility testing.

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