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KIT ComASP COLISTIN, clsi, eucast [Liofilchem-75001]

https://unicat.msf.org/cat/product/75412
STD SASTBRTHCS1

Valid Article

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.
15
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W0104080501 - Mic systems - dilution methods (incl. e-test)
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.
PM
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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KIT ComASP COLISTIN

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 16.

Definition

System for colistin susceptibility testing with the broth microdilution method.

ComASP Colistin is a 4-test panel containing the dried up antibiotic in 7 two-fold dilutions (0.25 - 16 μg/ml).

The system is used to perform the broth microdilution (BMD) method for the antimicrobial susceptibility testing of colistin (polymyxin E) as recommended by international standards (i.e. CLSI, EUCAST) .

Specifications

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Components

  • 4 Systems (panels) of ComASP Colistin (panels individually packed in foil with silica gel desiccant)
  • 16 Vials of Mueller Hinton II Broth (3.6 ml)
  • Sealing Film
  • Instructions Sheet and Test Results Form

Packaging & Labelling

4 x packs with 4 panels in the same pack

Instructions for use

  • A panel allows the susceptibility testing of 4 different isolates.
  • All wells in a single row (A, B, C or D) are rehydrated with a standardized microbial suspension.
  • After incubation in thermostat the result is read and interpreted.

Precautions for Use

ComASP Colistin is a disposable device to be used only for diagnostic use in vitro. The product must be used in the laboratory by properly trained personnel, using approved aseptic and safety methods for handling pathogenic agents.

Storage

  • Store ComASP Colistin at 2-8°C in the original packaging.
  • Once an envelope is opened the panel should be used within 7 days.
  • Keep away from direct sunlight and direct heat.
  • Do not use the panels beyond the expiry date indicated on the label.
  • Eliminate without using if there are signs of deterioration.
  • Shelf life: 15 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

(Cf Introduction: Thermosensitive products)

Waste management

After use, ComASP Colistin and material that has come into contact with the sample must be decontaminated and disposed of in accordance with guidelines used in the laboratory for decontamination and disposal of potentially infected material.

MSF requirements

Reserved for bacteriology culture programmes

This test can only be used with colistine in antibio which requires also approval of the referents for each order

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