Fisherbrand
Urisys Caps Neon Orange 500/CS
7manufacturers in China registered for this device type
11catalogue numbers in this listing
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 | Fisher Scientific Company L.L.C., United States |
|---|---|
| FDA product code | JXA |
| Device type | Kit, Screening, Urine |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Establishment | Complaint-file establishment |
| Premarket notification | Exempt |
| Record published | 2022-12-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Packaging | Case |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 14377255 | 500 | In distribution | |
| 14377254 | 500 | In distribution | |
| 14377258 | 500 | In distribution | |
| 14377251 | 500 | In distribution | |
| 14-375-206 | In distribution | ||
| 14-375-246 | 500 | In distribution | |
| 14377257 | 500 | In distribution | |
| 14377253 | 100 | In distribution | |
| 14-375-238 | 1,000 | In distribution | |
| 14377252 | 500 | In distribution | |
| 14377256 | 500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.