IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Type of Immunoassay/ Intended Used:
Quantitative determination of haemoglobin in capillary, venous and arterial whole blood, using a specially designed photometric analyser.
Description: The microcuvette serves both as a pipette and as a measuring cuvette and is for single use only.
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.
Packaging and Labelling:
50, 100, 200/Package Container
Instruction for use. (French, English and Spanish)
Product name, size, reference number, manufacture´s name and address, CE mark.
Harmonized 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:
The microcuvettes are to be stored at a temperature of 15–30 °C (59–86 °F) and in a dry place. The reagents in the micro-cuvette are moisture sensitive. Screw cap to be tightly closed after use.
Do not refrigerate.
Shelf life:
24 months from date of manufacture.
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
Safety & product Standards:
Must comply with following standards
EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
EN 13640:2002 Stability testing of in vitro diagnostic reagents
EN 13641:2002 Elimination of reduction of risk of infection related to in vitro diagnostic reagents
EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
ISO 18113-3:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
IEC 61010-2-101:2002 Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC 61326-2-6:2005 Electrical equipment for measurement, control and laboratory use - EMC requirements -- Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
IEC 62304:2006 Medical device software - Software life-cycle processes
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
Environmental requirements:
Rohs compliance
These technical specifications are generic and may vary depending on the selected Vendor.
Type of Immunoassay/ Intended Used:
Quantitative determination of haemoglobin in capillary, venous and arterial whole blood, using a specially designed photometric analyser.
Description: The microcuvette serves both as a pipette and as a measuring cuvette and is for single use only.
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.
Packaging and Labelling:
50, 100, 200/Package Container
Instruction for use. (French, English and Spanish)
Product name, size, reference number, manufacture´s name and address, CE mark.
Harmonized 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:
The microcuvettes are to be stored at a temperature of 15–30 °C (59–86 °F) and in a dry place. The reagents in the micro-cuvette are moisture sensitive. Screw cap to be tightly closed after use.
Do not refrigerate.
Shelf life:
24 months from date of manufacture.
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
Safety & product Standards:
Must comply with following standards
EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
EN 13640:2002 Stability testing of in vitro diagnostic reagents
EN 13641:2002 Elimination of reduction of risk of infection related to in vitro diagnostic reagents
EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
ISO 18113-3:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
IEC 61010-2-101:2002 Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC 61326-2-6:2005 Electrical equipment for measurement, control and laboratory use - EMC requirements -- Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
IEC 62304:2006 Medical device software - Software life-cycle processes
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
Environmental requirements:
Rohs compliance
| Pack Size | Avg. Price |
|---|---|
| Pack of 200 | $121.54 |
