IMPORTANT NOTE: These technical specifications are generic and may vary among suppliers.
Product name:
Urine Test – strips
Product code
Description: Test strips for urine analysis.
Parameters:
Glucose neg, 100, 250, 500, 1000, 2000 mg/dl, of more
Protein neg, trace, 30, 100, 300, 2000 mg/dl, of more
pH 5.0, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5
Leukocytes neg, trace, +, ++, +++
Nitrites neg, pos
Ketone neg, 5, 15, 40, 80, 150 mg/dl
Bilirubin neg, +, ++, +++
Blood neg, trace, moderate, haemolyzed, +, ++, +++
Urobilinogen 0.2, 1, 2, 4, 8 mg/dl
Specific gravity 1.000, 1.005, 1.010, 1.015, 1.020, 1.025, 1.030
Colour reference card is water resistant, wet-wipeable
Primary packaging – unbreakable and sealed
Reading time: Approximately 30 seconds to 2 minutes
Specimen of sample type to be used: Orine
Accessories:
Pouch, Specimen collection loops, test stand.
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: Test strip, urine, 10 parameter, box/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)
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
Environmental requirements: Rohs compliance
Product name:
Urine Test – strips
Product code
Description: Test strips for urine analysis.
Parameters:
Glucose neg, 100, 250, 500, 1000, 2000 mg/dl, of more
Protein neg, trace, 30, 100, 300, 2000 mg/dl, of more
pH 5.0, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5
Leukocytes neg, trace, +, ++, +++
Nitrites neg, pos
Ketone neg, 5, 15, 40, 80, 150 mg/dl
Bilirubin neg, +, ++, +++
Blood neg, trace, moderate, haemolyzed, +, ++, +++
Urobilinogen 0.2, 1, 2, 4, 8 mg/dl
Specific gravity 1.000, 1.005, 1.010, 1.015, 1.020, 1.025, 1.030
Colour reference card is water resistant, wet-wipeable
Primary packaging – unbreakable and sealed
Reading time: Approximately 30 seconds to 2 minutes
Specimen of sample type to be used: Orine
Accessories:
Pouch, Specimen collection loops, test stand.
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: Test strip, urine, 10 parameter, box/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)
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
Environmental requirements: Rohs compliance
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $7.38 |
