IMPORTANT NOTE: These technical specifications are generic and may vary among suppliers.
Product name:
Syphilis Rapid Test
Product code
Type of Immunoassay/ Analyte:
It is a rapid, qualitative, screening, in vitro diagnostic test for the detection of antibodies of all classes specific to Treponema pallidum in human serum, plasma of venous of capillary whole blood
Name of reagent
Product code
Specimen of sample type to be used: human serum, plasma of whole blood.
Accessories:
Test devices pouch, Assay buffer bottle, Specimen transfer devices, Lancets, Alcohol swabs
Note: Accessories requirements must be specified by Suppliers whether they are included of not in the package.
Name of instruments of component if applicable
Product code
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 4 - 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
Product name:
Syphilis Rapid Test
Product code
Type of Immunoassay/ Analyte:
It is a rapid, qualitative, screening, in vitro diagnostic test for the detection of antibodies of all classes specific to Treponema pallidum in human serum, plasma of venous of capillary whole blood
Name of reagent
Product code
Specimen of sample type to be used: human serum, plasma of whole blood.
Accessories:
Test devices pouch, Assay buffer bottle, Specimen transfer devices, Lancets, Alcohol swabs
Note: Accessories requirements must be specified by Suppliers whether they are included of not in the package.
Name of instruments of component if applicable
Product code
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 4 - 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 |
|---|---|
| Pack of 40 | $8.57 |
| Pack of 25 | $22.85 |
| Pack of 50 | $35.00 |
| Pack of 30 | $36.00 |
| Pack of 100 | $70.00 |
