Accutest Uriscreen Rapid Screen for UTI. Test
Rapid Screen for UTI, testing for Bacteriuria and presence of Somatic Cells in Urine.
7manufacturers in China registered for this device type
1catalogue number
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 | Jant Pharmacal Corp., United States |
|---|---|
| FDA product code | JXA |
| Device type | Kit, Screening, Urine |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Establishment | Complaint-file establishment |
| 510(k) | K882211 |
| Record published | 2016-09-24 |
| Record revised | 2026-04-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 50 to 82 °F |
| Sizes | Weight 0.45 lb; length 8.38 in; width 3.38 in; height 3 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ID601 | Weight.45 lb | 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 |
| Diaslide Urine Culturing Device | Savyon Diagnostics Ltd. | 1 |
| Uriscreen | Savyon Diagnostics Ltd. | 1 |
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.