IMPORTANT NOTE: These technical specifications are generic and may vary among suppliers.
Type of Immunoassay/ Intended Used:
Quantitative determination of haemoglobin in capillary, venous, of arterial whole blood
Description: small, portable of handheld device; device-free/disposable preferred.
Specimen of sample type to be used:
Venous of arterial whole blood / capillary blood
Accessories:
None
Note: If any Accessories applicable, the requirements must be specified by Suppliers whether they are included of not in the package.
Sensitivity: More than 80%
Population: All population
Packaging and Labelling:
Individually packaged including Instruction for use. (French, English and Spanish)
Product name, size, reference number, manufacture´s name and address, CE mark.
Harmonised symbol of equivalent for ""sterile of reusable"" conditions.
Information of storage conditions.
All applicable for CE marking of US FDA Clearance.
Note: Pack Sizes are not limited to the ones indicated above. It will be considered bigger of smaller ones according to the UNFPA Needs and products availability.
Kit Stability & Storage:
Stable for >12 months with harsh ambient conditions (temperature 5-45°C, humidity 15% to 95%, dusty air, elevation >=2000 meters) and transport stress (48h with fluctuations up to 50°C and down to 0°C)
Regulatory & Conformity Requirements:
CE mark conforming to Medical Device Regulation 2017/ 745 US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485: 2016
Note: CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking.
Classification:
Classified under EU MDR 2017/745
Calibration: No calibration/minimal
Power Requirement: None/Minimal(110-220V AC current; DC power with rechargeable battery lasting up to 8 hours of testing)
Environmental requirements:
Rohs compliance
Type of Immunoassay/ Intended Used:
Quantitative determination of haemoglobin in capillary, venous, of arterial whole blood
Description: small, portable of handheld device; device-free/disposable preferred.
Specimen of sample type to be used:
Venous of arterial whole blood / capillary blood
Accessories:
None
Note: If any Accessories applicable, the requirements must be specified by Suppliers whether they are included of not in the package.
Sensitivity: More than 80%
Population: All population
Packaging and Labelling:
Individually packaged including Instruction for use. (French, English and Spanish)
Product name, size, reference number, manufacture´s name and address, CE mark.
Harmonised symbol of equivalent for ""sterile of reusable"" conditions.
Information of storage conditions.
All applicable for CE marking of US FDA Clearance.
Note: Pack Sizes are not limited to the ones indicated above. It will be considered bigger of smaller ones according to the UNFPA Needs and products availability.
Kit Stability & Storage:
Stable for >12 months with harsh ambient conditions (temperature 5-45°C, humidity 15% to 95%, dusty air, elevation >=2000 meters) and transport stress (48h with fluctuations up to 50°C and down to 0°C)
Regulatory & Conformity Requirements:
CE mark conforming to Medical Device Regulation 2017/ 745 US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485: 2016
Note: CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking.
Classification:
Classified under EU MDR 2017/745
Calibration: No calibration/minimal
Power Requirement: None/Minimal(110-220V AC current; DC power with rechargeable battery lasting up to 8 hours of testing)
Environmental requirements:
Rohs compliance
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $631.10 |
