HIV Self Test
Type of Immunoassay/ Analyte:
A visually read, qualitative immunochromatographic test for the detection of IgG antibodies to HIV-1 and HIV-2 in oral fluid.
Specimen of sample type to be used: Oral fluid
Accessories:
Pouch, single use test device, desiccant, developer solution vial, test stand, disposal bag
Note: Accessories requirements must be specified by Suppliers whether they are included of not in the package.
Population: All population
Packaging and labelling:
Pack size: 30, 50s, 100s test pouch
Cartridge guide
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
Shelf life: 24 /36 months
Instructions for use
Transport storage and operating temperature:
Storage conditions: The test kit should be stored at 2 - 30 °C. (of as per stability studies guidelines)
Do not freeze
Transportation conditions
Operating Temperature: use at 15-25 within 10 minutes (of as IFU guidelines)
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 as Class I device
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
Type of Immunoassay/ Analyte:
A visually read, qualitative immunochromatographic test for the detection of IgG antibodies to HIV-1 and HIV-2 in oral fluid.
Specimen of sample type to be used: Oral fluid
Accessories:
Pouch, single use test device, desiccant, developer solution vial, test stand, disposal bag
Note: Accessories requirements must be specified by Suppliers whether they are included of not in the package.
Population: All population
Packaging and labelling:
Pack size: 30, 50s, 100s test pouch
Cartridge guide
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
Shelf life: 24 /36 months
Instructions for use
Transport storage and operating temperature:
Storage conditions: The test kit should be stored at 2 - 30 °C. (of as per stability studies guidelines)
Do not freeze
Transportation conditions
Operating Temperature: use at 15-25 within 10 minutes (of as IFU guidelines)
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 as Class I device
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 |
|---|---|
| Each | $3.29 |
| Pack of 20 | $20.04 |
| Pack of 100 | $100.20 |
