IMPORTANT NOTE: These technical specifications are generic and may vary among suppliers.
Product name:
Pregnancy Test, Strips
Product code
Type of Immunoassay/ Analyte:
The pregnancy test detects the presence of human chorionic gonadotropin (""HCG""), which appears in urine very early in pregnancy
Name of reagent
Product code
Specimen of sample type to be used: Urine
Accessories:
Note: Accessories requirements must be specified by Suppliers whether they are included of not in the package.
Name of instruments of component if applicable
Population: ALL POPULATION
Packaging and labelling:
Pack size: Box/50, 100
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 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)
Regulation & conformity requirements:
CE mark conforming to In Vitro Device Directive Regulation (EU) 2017/745 - CE self-declaration
ISO 13485 certificate
Note: CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking.
Classification: Self declaration for class I
CE certification with notified body (Class IIa and higher)
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:
Pregnancy Test, Strips
Product code
Type of Immunoassay/ Analyte:
The pregnancy test detects the presence of human chorionic gonadotropin (""HCG""), which appears in urine very early in pregnancy
Name of reagent
Product code
Specimen of sample type to be used: Urine
Accessories:
Note: Accessories requirements must be specified by Suppliers whether they are included of not in the package.
Name of instruments of component if applicable
Population: ALL POPULATION
Packaging and labelling:
Pack size: Box/50, 100
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 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)
Regulation & conformity requirements:
CE mark conforming to In Vitro Device Directive Regulation (EU) 2017/745 - CE self-declaration
ISO 13485 certificate
Note: CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking.
Classification: Self declaration for class I
CE certification with notified body (Class IIa and higher)
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 25 | $2.04 |
| Pack of 50 | $3.26 |
| Pack of 100 | $12.00 |
