(CD4 analyser FACSPresto) TEST CARTRIDGE, wb,1 test, 657681

STD ELAECD4T603

Valid Article

Former Code(s): DDGTZBE0208
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.
12
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
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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(CD4 FACSPresto) TEST CARTRIDGE

Definition

Cartridge to be used with the BD FACSPresto CD4 analyzer providing absolute and percentage results of CD4 T lymphocytes and total haemoglobin concentration in venous and capillary blood samples.

Specifications

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Components

BD FACSPresto™ Cartridge packaging includes:

  • BD FACSPresto™ Cartridge (100 tests)
  • BD™ Disposable Pipettes (100 pipettes)
  • Cartridge Instruction for use

Technical specifications

1 cartridge is aimed to perform the test for 1 patient

1 measurement takes 18 minutes (incubation - out of the machine) + 4 minutes reading

Instructions for use

Please consult the “Updated laboratory procedures, 2022” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources.

https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Laboratory-Manual-page.aspx

For offline access, contact your laboratory advisor.

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Storage

  • In its original foil pouch.
  • Do not use the cartridge if the pouch has been opened for more than 30 minutes
  • Store between: 4 and 31°C
  • 10%–95% non-condensing humidity
  • Shelf life: 12 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life
  • Until the expiration date. Do not use the cartridge after the expiration date on the package

(Cf Introduction: Thermosensitive products)

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