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(BACTEC MGIT) SIRE Kit, 40 tests, kit [BD-245123]

https://unicat.msf.org/cat/product/13424
STD ELAEMDSC109

Valid Article

Former Code(s): SLASSIRE40- ELAEMGIT104 ELAEMGIC109
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.
P
The order of this product needs to be justified and is only acceptable under certain conditions.
0208
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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(BACTEC MGIT) SIRE Kit

Reserved for TB culture programmes.

Definition

Supplement and four antibiotic vials to perform susceptibility testing of M. tuberculosis complex on the first line TB drugs with MGIT960 automated system, 7ml tubes.

The MGIT960 SIRE kit is a qualitative test. The instrument monitors fluorescence in the tubes comparing the growth of M. tuberculosis strain in drug-containing tubes to the drug-free tube, in order to determine resistance.

Specifications

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Technical specifications

  • White powder, rifampicin red
  • Soluble in water
  • 40 tests - each reconstituted vial, of 4 ml volume, is enough for slightly less than 40 tubes, as dispertion of material must be taken into account.

Packaging & Labelling

The kit contains one each lyophilized vials of streptomycin, isoniazid, rifampicin and ethambutol and eight vials of SIRE Supplement.

Instructions for use

Reconstitute each antibiotic vial with 4 ml sterile distilled water then alliquot 110µl of each mixture in cryotubes for storage at -20°C or cooler. Before starting the test, thaw one reconstituted vial for each antibiotic then proceed according to manuafacturer instructions.

Storage

  • On receipt, store the lyophilized drug vials in the refrigerator between 2° and 8°C
  • Once reconstituted, the antibiotic solutions may be frozen and stored at -20°C or colder up to six months, not to exceed the original expiration date.
  • Once thawed, use immediately and discard unused portions of reconstituted antibiotics.
  • Shelf life: 18 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

(Cf Introduction: Thermosensitive products)

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