Uriscreen
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…
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.
7manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jilin (5), Shandong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Weihai Kangzhou Biotechnology Engineering Co., Ltd. | Weihai | Shandong | Manufacturer | 24 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Changchun LYZ Technology Co., Ltd. | Changchun | Jilin | Manufacturer | 16 |
| Jilin Test BIO-Electron Co., Ltd. | Changchun | Jilin | Manufacturer | 9 |
Record
| Listed by | Savyon Diagnostics Ltd., Israel |
|---|---|
| FDA product code | JXA |
| Device type | Kit, Screening, Urine |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2026-04-29 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 28 °C; Handling environment temperature 10 to 28 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 101-01 | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fisherbrand | Fisher Scientific Company L.L.C. | 11 |
| Cardinal Health | Cardinal Health 200, LLC | 11 |
| Chromid® CPS® Elite agar/Columbia CNA agar + 5% sheep blood | bioMerieux, Inc. | 1 |
| Chromid® CPS® Elite Agar (Cpse) | bioMerieux, Inc. | 1 |
| Tri-Tech Forensics, Inc. | TRI-Tech Forensics, Inc. | 1 |
| Chromid® CPS® Elite Agar (Cpso) | bioMerieux, Inc. | 1 |
| Know Rapid STD Test | MobiLab Medical Innovatives Inc. | 1 |
| MobiLab Standard Sexual Health Self Rapid Test | MobiLab Medical Innovatives Inc. | 1 |
| Accutest Uriscreen Rapid Screen for UTI. Test | Jant Pharmacal Corp. | 1 |
| Diaslide Urine Culturing Device | Savyon Diagnostics Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K921045 | 1992-09-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.