(MicroMGIT) AST SIRE KIT, lyophil.,8 tubes, kit [BD-245119]

STD ELAEFLUC304

Valid Article

Former Code(s): SLASASTS4--
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.
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) ANTIBIOTIC AST SIRE KIT for BBL MGIT

Reserved for TB culture programmes.

Definition

Four antibiotics kit for susceptibility testing of Mycobacterium tuberculosis.

BBL MGIT AST SIRE System

The test is based on the growth of Mycobacterium tuberculosis strain in drug-containing tube compared to drug-free tube. Tubes are observed daily starting from the third day after inoculum. Absence of fluorescence in the drug-containing tube two days after appearance of fluorescence in the growth control tube is a sign of susceptibility of the Mycobacterium to the drug, while appearance of fluorescence on the drug-containing tube on or within two days of fluorescence of Growth Control tube indicates resistance. Appearance of fluorescence is based on the same principle explained for BBL MGIT 4 ml tubes.

Specifications

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Technical specifications

  • White powder
  • Soluble in water
  • 2 x 4 lyophilized vials: Streptomycin, Isoniazid, Rifampin, Ethambutol
  • sufficient for 80 SIRE tests

Packaging & Labelling

  • 2 x 4 lyophilised vials
  • Transport not regulated

Instructions for use

Reconstitute each vial of antibiotic with 4 ml sterile distilled water. Label 4 tubes for each Mycobacterial strain tot test. Add 100 μl of each antibiotic solution to the labelled tube containing the mycobacterial suspension.

Storage

  • Keep lyophilized vials refrigerated between 2º C and 8º C
  • Once reconstituted, antibiotics are to be stored in aliquots at -20°C up to 6 months
  • Once thawed, use immediately and discard unused portions
  • Shelf life: 12 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

(Cf Introduction: Thermosensitive products)

MSF requirements

Each reconstituted vial, of 4 ml volume, is enough for slightly less than 40 tubes, as dispersion of material must be taken into account.

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