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Basic Information
- Primary DI
- D-693748520UX
- Basic UDI-DI Code
- B-693748520UX
- Reference
- Uric 10 CF, Uric 4VSG, Uric 2VGK, Uric 2VGP, Uric 3V, Uric 4V
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Guilin Zhonghui Technology Co., Ltd.
Additional Description
Urine Analysis Test Strips are intended use in the home to provide tests for the semi-quantitative determination of Ascorbic acid, Glucose, Bilirubin, Ketone (acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in Urine. Screening test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and urinary tract infection. It is measured by comparison of test paper attached to a plastic strip with the color chart blocks printed on the vial label. The strips may be read visually.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060201 | URINE SINGLE TEST STRIPS (INCL. TABLETS) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2095991-1 | TÜV Rheinland LGA Products GmbH | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Self Testing) and regulation (EU IVDD).