PoC CD4 [abs] cartridge kit,100 tests

General Description
Point-of-Care (PoC) CD4 [absolute] counter, cartridge kit, 100 tests.

Technical Specifications
Dedicated single-use testing cartridges for with item S0001224 PoC CD4 [abs], counter, portable with start kit or item S0001242 PoC CD4 [abs], portable counter, with start kit and accessories
Contains all necessary reagents to complete CD4 enumeration, from whole blood sample to test-result
Design of cartridge: capping of the cartridge after sample collection ensure a closed system eliminating any possibility of cross contamination. Single use device that once capped cannot be used again.
Sample collected: 25 µl whole blood
Labelled with bar-code for easy identification by the counter, including expiry date
Box of 100 cartridges sealed in an aluminum pouch.

Manufacture product reference: 260 100 100 (Alere)

Supplied with
1 x package insert in English, French and Spanish

Shelf life
Min. 8 months - max. 12 months. Upon delivery, the cartridge kits must have minimum 8 months of the total 12 months shelf-life remaining. Do not use beyond its expiry date.

Storage and transportation
Between 2 - 30ºC, protected against humidity and direct sunlight. Do not freeze.

Note
Do not substitute reagents from other kits/batches.
Follow strictly manufacturer instructions of the test procedure (especially adherence to reading time).

Packaging and Labeling:
Primary packaging
Unit presentation: 1 (one) PoC CD4 [abs], cartridge kit, 1 test and package insert packed and sealed in an aluminium pouch with desiccant

Secondary packaging
Kit of 100 unit presentations and instructions for use must be contained in one box

Packaging and labelling must meet essential requirements in conformity with international quality management system standards, norms, rules and regulations for medical devices. Refer to UNICEF Technical Provisions for Medical Devices- March 2014



Shipping
The manufacturer shall be responsible to comply with full extend to the most current edition of Dangerous Goods Regulations (DGR), as applicable. UNICEF shall be provided with the relevant MSDS hazardous goods shipping code in the event the quantity of hazardous materials exceeds the tolerance limit.

Weight and Volume:
Estimated weight: 1.9kg
Estimated volume: 12.6cdm