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CHOLERA TEST Ag O1/O139, stool, 1 test (Bioline 44FK30)

https://medicalguidelines.msf.org/en/node/800
https://unicat.msf.org/cat/product/71815
NST SSDTCHOL20T

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.
W0105011799 - Bacteriology - immunoassay other
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.
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://www.unicat.msf.org/web/image/product.template/580210/image_1920?unique=e366ec3

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CHOLERA TEST Ag O1/O139 (Bioline)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged per 20 tests.

Definition

Rapid lateral flow assay for the qualitative screening test for detection of LPS antigen of both Vibrio cholera O1 and O139 in human stool specimen. .

Specifications

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Components

  • 20 Test devices with desiccant in individual foil pouches
  • Specimen collection tubes containing extraction buffer (20 x 1.2 ml/vial)
  • 20 Swabs for solid specimen collection
  • 20 Disposable droppers for liquid specimen collection
  • 20 Patient identification labels
  • 1 Instructions for use

Technical specifications

  • Time to result: 15 min
  • Specimen: Solid (50mg) or liquid stool (300µl)
  • Assay diluent: incolor liquid

Packaging & Labelling

Kit of 20 tests

Transport Dangerous Goods

Transport not regulated

Instructions for use

Follow the instructions on the leaflet and the protocol for the investigation of an epidemic.

  • Not to be used for individual diagnosis.
  • The test does not detect V. cholera non-O1/O139
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Precautions for Use

All biological samples must be treated as potentially infectious and handled with the usual precautions (compulsory wearing of gloves, hand washing, etc.).

Storage

  • Store between 1ºC and 30º C
  • Do not freeze
  • Shelf life: 24 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life
  • Not to be used beyond expiry date

Waste management

Incinerate the tests and the used materials.

Classification EC Regulation N° 1272/2008

Diluent not classified as hazardous

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