Product Name: Urine Test – Strips
Description:
Test strips for urine analysis.
Parameters:
Glucose: neg, 100, 250, 500, 1000, 2000 mg/dl, or more
Protein: neg, trace, 30, 100, 300, 2000 mg/dl, or 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, hemolyzed, +, ++, +++
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:
Water resistant, wet-wipeable.
Primary Packaging: Unbreakable and sealed.
Reading Time: Approximately 30 seconds to 2 minutes.
Specimen or Sample Type to Be Used: Urine.
Accessories:
Pouch, specimen collection loops, test stand.
Name of Instruments or Component, if Applicable:
Product Code
Packaging and Labelling:
Pack size: Test strip, urine, 10 parameters.
Shelf Life:
24/36 months
Instructions for Use
Transport, Storage, and Operating Temperature:
Storage Conditions: The test strips should be stored at 2-30°C (or as per stability studies guidelines).
Do not freeze.
Transportation Conditions:
Operating Temperature: Use at 15-25°C within 10 minutes (or as per IFU guidelines).
Regulatory & Conformity Requirements:
CE mark conforming to Medical Device Regulation 2017/745 or 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 the CE marking.
Classification: Classified under EU MDR 2017/745 as a Class I device.
Environmental Requirements: RoHS compliance.
Description:
Test strips for urine analysis.
Parameters:
Glucose: neg, 100, 250, 500, 1000, 2000 mg/dl, or more
Protein: neg, trace, 30, 100, 300, 2000 mg/dl, or 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, hemolyzed, +, ++, +++
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:
Water resistant, wet-wipeable.
Primary Packaging: Unbreakable and sealed.
Reading Time: Approximately 30 seconds to 2 minutes.
Specimen or Sample Type to Be Used: Urine.
Accessories:
Pouch, specimen collection loops, test stand.
Name of Instruments or Component, if Applicable:
Product Code
Packaging and Labelling:
Pack size: Test strip, urine, 10 parameters.
Shelf Life:
24/36 months
Instructions for Use
Transport, Storage, and Operating Temperature:
Storage Conditions: The test strips should be stored at 2-30°C (or as per stability studies guidelines).
Do not freeze.
Transportation Conditions:
Operating Temperature: Use at 15-25°C within 10 minutes (or as per IFU guidelines).
Regulatory & Conformity Requirements:
CE mark conforming to Medical Device Regulation 2017/745 or 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 the CE marking.
Classification: Classified under EU MDR 2017/745 as a Class I device.
Environmental Requirements: RoHS compliance.
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $7.38 |
