Product Name: Chemical Urinalysis Urine Tset Strip

Registrant: WEIHAI KANGZHENG MEDICAL EQUIPMENTS TECHNOLOGY CO.,LTD

Management category: Class II medical devices

Packaging specifications: 1 piece/bag, 25 pieces/bag, 25 pieces/bottle, 50 pieces/bottle, 100 pieces/bottle, 125 pieces/bottle, etc.

Product Overview: This product consists of test strips impregnated with various chemical reagent modules. They react chemically with specific components in urine, and perform semi-quantitative or qualitative analysis based on the color change of the modules.

Intended Use: For in vitro qualitative or semi-quantitative analysis of multiple chemical components in human urine, including glucose, bilirubin, ketone bodies, specific gravity, occult blood, pH, protein, urobilinogen, nitrite, and leukocyte esterase, to assist in assessing human health.
The test results are for clinical reference only and should not be used as the sole basis for clinical diagnosis. A comprehensive assessment should be made in conjunction with other clinical indicators and examination results.

Working Principle: Each reagent module on the test strip contains a specific chemical reaction reagent. When the test strip is dipped into a urine sample, each reagent module reacts with the corresponding chemical component in the urine, producing a visible color change within a specified timeframe.
The test results for each item are obtained by comparing the resulting color with a standard colorimetric chart.

14 test items and their clinical significance:
Glucose (GLU): Assists in screening for diabetes and renal glycosuria
Protein (PRO): Indicates kidney disease (nephritis, nephrotic syndrome)
Blood occult blood (BLD): Reflects urinary tract bleeding or glomerular damage
White blood cells (LEU): Indicates urinary tract infection (sensitivity 94.2%)
Nitrite (NIT): Indicates bacterial infection such as Escherichia coli
Ketone bodies (KET): Found in diabetic ketoacidosis and prolonged starvation
Bilirubin (BIL)/urobilinogen (URO): Assess liver and gallbladder function
pH: Reflects acid-base balance
Specific gravity (SG): Assess kidney concentrating function
Microalbumin (MA): Detects early kidney damage
Creatinine (Cr): Assess glomerular filtration function
Urine calcium (Ca): Indicates parathyroid dysfunction
Vitamin C (VC): Reference indicator for interfering factors

Product Advantages
Flexibility: Simultaneously detects 1-14 key indicators in urine, assisting clinical diagnosis and health monitoring.
Accuracy: Superior analytical sensitivity and high-precision colorimetric system: Multi-gradient color chart, interpretation error <3%.
Anti-VC interference technology: Reduces vitamin C interference in testing.
Double moisture-proof design: Unopened product has an 18-month shelf life, opened product has a 3-month shelf life.
Customizable packaging: Packaging options adaptable to various usage scenarios, fast and convenient.

Instructions:
Midstream urine collection: Collect midstream urine in a urine cup (avoid contamination).
Immerse: Immerse the test strip completely in urine for 2 seconds, then remove.
Wait: Remove excess urine and allow the test strip to develop color for 30 seconds.
Compare: Compare to a color chart within 2 minutes.

Precautions
1. Professional Use: This product should be used under the guidance of a qualified medical professional or by referring to the instructions in the package insert.
2. Not for Diagnosis: The test results provide only auxiliary diagnostic information and should not be used as the sole basis for clinical diagnosis. A comprehensive assessment must be made in conjunction with the patient's symptoms, physical signs, and other laboratory test results.
3. Sample Requirements: Fresh urine samples must be used, and testing must be completed within the specified timeframe to prevent degradation of chemical components that may affect the accuracy of the results. Women should avoid testing during menstruation to avoid contamination.
4. Single-use test; do not touch the reaction area.
5. Interfering Substances: Certain medications or foods may interfere with test results. Consult the instructions before use.
6. Storage: Store in a cool, dry, and dark place. Seal the bottle cap immediately after each use to prevent moisture and ineffectiveness of the test strip.
7. Please carefully read the product instructions for specific operating procedures, result interpretation, precautions, and limitations.

Precautions
1. Professional Use: This product should be used under the guidance of professional medical personnel or by referring to the instructions.
2. Not for Diagnostic Purposes: Test results provide supplementary diagnostic information only and should not be used as the sole basis for clinical diagnosis. A comprehensive judgment must be made based on the patient's symptoms, signs, and other laboratory test results.
3. Sample Requirements: Fresh urine samples must be used, and the test must be completed within the specified time to avoid chemical degradation affecting the accuracy of the results. Women should avoid testing during menstruation to prevent contamination.
4. Single Use Only; Do not touch the reaction area.
5. Interfering Substances: Certain medications or foods may interfere with test results. Refer to the instructions before use.
6. Storage Conditions: Store in a cool, dry, and dark place. Seal the cap immediately after each use to prevent the test strip from becoming damp and ineffective.
7. For detailed operating procedures, result interpretation methods, precautions, and limitations, please read the product instructions carefully.

Please read the product instructions carefully or purchase and use under the guidance of medical personnel.

For contraindications or precautions, please refer to the instruction manual.