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

https://unicat.msf.org/cat/product/18738
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.
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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(MicroMGIT) ANTIBIOTIC AST SIRE KIT for BBL MGIT

Reserved for TB culture programmes.

Definition

Four antibiotics kit for susceptibility testing of Mycobacterium tuberculosis in culture.

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)

Waste management

Presence of substance with hazardous properties. Please contact yourwatsan referent for advice on proper disposal.

Detailed hazard and precautionary information can be found in the safety data sheet (SDS).

Classification EC Regulation N° 1272/2008

BBL MGIT AST SIRE - Rifampin, Lyophilized:

  • Acute toxicity (Oral), Category 4, H302
  • Acute toxicity (Inhalation - dust and mist), Category 4, H332

BBL MGIT AST SIRE - Ethambutol, Lyophilized

  • Health Hazards Toxic to reproduction, Category 1A, H360
Image Image

Signal Word

Warning for Rifampicine

Danger for Ethambutol

H360May damage fertility or the unborn child (state specific effect if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)
H302 + H332Harmful if swallowed or if inhaled
P405Store locked up.
P201Obtain special instructions before use.
P202Do not handle until all safety precautions have been read and understood.
P261Avoid breathing dust/fume/gas/mist/vapours/spray.
P270Do not eat, drink or smoke when using this product.
P271Use only outdoors or in a well-ventilated area.
P264Wash … thoroughly after handling
P280Wear protective gloves/protective clothing/eye protection/face protection
P312Call a POISON CENTER or doctor/physician if you feel unwell.
P330Rinse mouth.
P301 + P312IF SWALLOWED: call a POISON CENTER or doctor/physician if you feel
P304 + P340IF INHALED: Remove to fresh air and keep at rest in a position comfortable for breathing.
P308 + P313IF exposed or concerned: Get medical advice/attention.
P501Dispose of contents/container to location in accordance with local and regional/ national/ international regulations

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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