URISCREEN
- Primary DI
- 07290013348531
- Brand
- URISCREEN
- Company
- SAVYON DIAGNOSTICS LTD
- Model
- 101-01
- Device description
- URISCREEN is a rapid screening test for UTI. The test is primarily intended for the screening of asymptomatic populations for significant bacteriuria, hematuria, pyuria and the presence of other somatic cells in urine.
- Published
- 2026-04-29
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- OTC
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| JXA | Kit, Screening, Urine |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| JXA | Kit, Screening, Urine | Microbiology | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07290013348531 | Primary | GS1 | 0 | |
| 17290013348538 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07290013348531 | 07290013348531 | 7290013348531 |
| 17290013348538 | 17290013348538 |
GMDN Terms#
| Term | Definition |
|---|---|
| Urine catalase IVD, kit, rapid colorimetric, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for catalase within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Temperature | 10 Degrees Celsius | 28 Degrees Celsius | |
| Storage Environment Temperature | 10 Degrees Celsius | 28 Degrees Celsius |
Regulatory Flags#
- DUNS number
- 533708202
- Device count
- 20
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07290006418326 | CHROMOSTREAK | BD-915 | BD-915 | 2026-05-27 |
| 07290006418111 | DIASLIDE URINE CULTURING DEVICE | DS-105 | 2026-05-04 | |
| 17290006558937 | Feminine Screening Kit | F-1-VO-CVS02 | 2026-02-22 | |
| 07290006558930 | Feminine Screening Kit | F-1-VO-CVS02 | 2026-02-22 | |
| 07290001913147 | SeroELISA Chlamydia IgG | A111-01 | A111-01 | 2025-05-29 |
| 07290001913161 | SeroELISA Chlamydia IgA | A113-01 | 2025-05-29 | |
| 07290013348302 | Conjugate IgA | FA233-12M | FA233-12M | 2023-06-29 |
| 07290013348470 | Conjugate IgM | FA232-12M | FA232-12M | 2023-06-29 |
| 07290016332193 | Serum Diluent IgM | FB262-03M | FB262-03M | 2023-06-29 |
| 07290016332636 | Bordetella Pertussis IgG | A2231-01M | A2231-01M | 2023-06-16 |
| 07290013348487 | Bordetella immunology reagents IgA | 2233-01 | 2233-01 | 2023-06-29 |
| 07290013348494 | Bordetella immunology reagents IgM | 2232-01 | 2232-01 | 2023-06-29 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07290006418111 | DIASLIDE URINE CULTURING DEVICE | SAVYON DIAGNOSTICS LTD | JXA | 2026-05-04 |
| 50885380070271 | CARDINAL HEALTH | Cardinal Health 200, LLC | JXA | 2024-02-28 |
| 00860008737359 | Know Rapid STD Test | MobiLab Medical Innovatives Inc. | JXA | 2024-02-06 |
| 00860008737304 | MobiLab Standard Sexual Health Self Rapid Test | MobiLab Medical Innovatives Inc. | JXA | 2024-02-05 |
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| 20613647003620 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | JXA | 2022-12-07 |
| 20613647003637 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | JXA | 2022-12-07 |
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| 20613647003705 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | JXA | 2022-12-07 |
| 20613647003712 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | JXA | 2022-12-07 |
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