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(CD4 Partec Cyflow II) REAGENT KIT, absol.,100 tests 05-8401

https://unicat.msf.org/cat/product/13300
NST ELAECD4T201

Valid Article

Former Code(s): SLASCYFCKR1
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.
14
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
0208
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 Partec Cyflow II) REAGENT KIT CD4

Definition

The CD4 easy count kit is a two-component, quantitative test for absolute count of CD4+ T cell subpopulation of lymphocytes in adult venous EDTA whole blood using the Partec Cyflow Counter.
Absolute CD4+ T cell count is an indicator for the initiation or follow-up of treatment for people living with HIV, in conjunction with other laboratory and clinical findings.

The CD4% easy count kit is a four-component, quantitative test for leukocytes andthe CD4+ T cell subpopulation of lymphocytes in adult venous EDTA whole blood, which can then be enumerated with a suitable Sysmex Partec IVD flow cytometer.

The CD4+ T cell concentration and CD4% of lymphocytes in blood samples are useful to assess the immune and clinical status of patients. They are indicators for the initiation or follow-up of treatmentfor people living with HIV, in conjunction with other laboratory and clinical findings.

Specifications

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Components

CD4 easy count kit:

  • 05-8401-01: Vial containig CD4 mAb PE in PBS buffer with 0.2% BSA and 0.09% sodium azide
  • 05-8401-02: Bottle containing no lyse buffer is a PBS-based solution containing 0.09% sodium azide

CD4 % easy count kit:

  • 05-8405-01: Vial containing CD4 mAb PE : murine monoclonal antibodies supplied in PBS buffer with 0.2% BSA and 0.09% sodium azide
  • 05-8405-02: Vial containing CD45 mAb PE-Cy5 : murine monoclonal antibodies supplied in PBS buffer with 0.2% BSA and 0.09% sodium azide
  • 05-8405-03: Buffer 1 : PBS-based solutions containing 0.09% sodium azide
  • 05-8405-04: Buffer 2: PBS-based solutions containing 0.09% sodium azide

Technical specifications

  • Colourless liquids
  • Ready to use
  • CD4 easy count kit:
    • Human CD4 - Isotype IgG1 - Fluorochrome PE
  • CD4 % easy count kit:
    • Human CD4 - Isotype IgG1 - Fluorochrome PE
    • Human CD45 - Isotype IgG1 - Fluorochrome PE-Cy5
  • Samples: adult venous EDTA whole blood

Packaging & Labelling

Kit for 100 tests

Transport Dangerous Goods

Transport not regulated

Instructions for use

Precautions for Use

All biologicalsamples must beconsidered as potentiallyinfectious and handledwith the usualprecautions (compulsorywearing of gloves, hand washing, ...)

Storage

  • Keep refrigerated between 2 and 8ºC
  • Shelf life: 14 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life
  • Keep in the dark and keep away from direct sunlight
  • Do not freeze and do not expose to elevated temperatures

(Cf Introduction: Thermosensitive products)

Classification EC Regulation N° 1272/2008

Not classified as hazardous

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