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(mb GeneXpert IV) Xpert CHECK KIT, XPERTCHECK-CE-5

https://unicat.msf.org/cat/product/54072
STD ELAEMBIC114

Valid Article

Former Code(s): ELAEPCRC114 ELAEZNL0620 ELAEPCRC112 ELAEMBIC112
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.
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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(molecular biology GeneXpert) CHECK KIT

Definition

Xpert Check performs on-site checking of the GeneXpert GX-IV.

It is a first line system diagnostic tool in conjunction with an annual preventive maintenance service visit.

The Xpert Check kit is intended to replace Xpert Calibration kit GXCAL-CE-5.

Specifications

Compatible with 6- and 10-color modules

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Components

  • 5 pouches with each one cartridge
  • 1 CD-ROM with software and package insert
  • 4 I-CORE Lens Cleaning Brushes
  • 1 empty data CD (if offline feature is used)

Note: one Xpert Check kit per every four modules

Technical specifications

Software version required 4.0

Dimensions

  • W x H x D: 23 cm x 17 cm x 14 cm
  • Weight: 0.4 kg

Instructions for use

Contact your laboratory advisor for performing the quality control of the GeneXpert.

  • Run the Xpert Check Kit annually on GeneXpert devices.
  • Xpert Check is run by service personnel or a trained customer
  • Module calibration is now moved to a performance basis and will be handled via module exchange as needed
  • Only perform calibration when indicated necessary by Xpert Check
  • Failure of Xpert Check does not “lock out” the system or module

Storage

  • Store between 2 and 28°C
  • Shelf Life:
    • 24 months
    • up to 48 hours between 2 and 28°C once pouch is opened

(Cf Introduction: Thermosensitive products)

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