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(mb GeneXpert) VAGINAL & ENDOCERVICAL KIT CT/NG SWAB/A-50

https://unicat.msf.org/cat/product/70181
NST ELAEMBIC116

Valid Article

The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
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.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
CT30
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)
https://unicat.msf.org/web/image/product.template/588611/image_1920?unique=1f33d24

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(mb GeneXpert) CT/NG VAGINAL & ENDOCERVICAL KIT SWAB-A50

Definition

Swab with tube to collect, preserve and transport endocervical and vaginal specimens prior to analysis with the Xpert cartridges

Specifications

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Components

50 kits per box containing:

  • 1 large sterile cleaning swab‌, individuallly wrapped
  • 1 flocked collection swab, individualllywrapped
  • 1 tube swab transport reagent (pink cap
  • )Instruction for collection of specimen (patient)-collected vaginal swab‌ (50 per box
  • )Instruction for collection of endocervical swabs and clinicial collected (1 per box)

Technical specifications

  • Transportation temperature: 2-30°C
  • Transport reagent is a clear, colorless and odorless liquid

Packaging & Labelling

50 kits/ pack

Instructions for use

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Storage

  • To be stored at 2 to 30 °C
  • Shelflife up to 36 months

Classification EC Regulation N° 1272/2008

Not classified as hazardous

MSF requirements

Used for testing for Chlamydia trachomatis and Neisseria gonorrhoeae using the Xpert CT/GN cartridge, and Trichomonas vaginalis using the on TV Xpert cartridge.

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Validated by Dominique Beels, laboratory advisor. July 2025