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(mb GeneXpert) URINE COLLECTION KIT, URINE/A-50

https://unicat.msf.org/cat/product/86409
NST ELAEMBIC125

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.
UN3082
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
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/589159/image_1920?unique=4d3503f

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(mb GeneXpert) URINE COLLECTION KIT

Definition

The Xpert Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and/or the Xpert TV Assay.

The Xpert Urine Collection Kit is intended for male and female urine.

Specifications

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Material

Urine Transport Reagent contains Ammonium chloride and Potassium carbonate

Components

Each kit contains a sealed package containing:

  • 1 tube containing Xpert urine transport reagent (yellow cap)
  • 1 sterile disposable transfer pipette (individually wrapped)
  • 1 Instructions for use
  • 1 Instruction for transfer of urine to collection kit

Technical specifications

  • Transport reagent is a clear, colorless and odorless liquid
  • Sample: first-catch urine
  • Sample volume: 7 ml

Packaging & Labelling

Xpert Urine Specimen Collection Kits contains 50 kits

Transport Dangerous Goods

Transport non regulated

Instructions for use

Refer to the package insert for the Xpert CT/NG Assay or the Xpert TV Assay, as applicable

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Precautions for Use

Use this collection kit only with the Xpert CT/NG Assay or the Xpert
TV Assay.

Storage

  • Store the kit at 2 to 30°C
  • Shelflife up to 36 months

Waste management

Substance with hazardous characteristics. Please contact your watsan 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

Eye irritation 2 - H319

Image

Signal Word

Warning

H319Causes serious eye irritation
P264Wash … thoroughly after handling
P280Wear protective gloves/protective clothing/eye protection/face protection
P305 + P351 + P338IF IN EYES: rinse cautiously with water for several minutes. If the victim wears contact lenses, remove them if possible. Keep rinsing
P337 + P313If eye irritation persists: get medical advice/attention

MSF requirements

Use with the Xpert CT/NG and/or the Xpert TV cartridges.

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Validated by Donal Doyle - microbiology referent - OCA (october 2025)