Dipstreak
DipStreak Urine Culture Devices are convenient means for transporting urine samples as well as for isolating, enumerating and identifying specific bacteria in urine
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong Huankai Biology SCI.&Tech.co., Ltd. | Zhaoqing | Guangdong | Manufacturer | 2 |
Record
| Listed by | Savyon Diagnostics Ltd., Israel |
|---|---|
| FDA product code | JSI |
| Device type | Culture Media, Selective And Differential |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2360 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K974428 |
| Record published | 2026-06-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 2 to 25 °C; Storage environment temperature 2 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| BD-510 | 10 | In distribution |
Same Product Code
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|---|---|---|
| Remel | Remel, Inc. | 137 |
| Culture Media, Selective And Differential | Hardy Diagnostics | 102 |
| Edge Biologicals Inc | Edge Biologicals, Inc. | 40 |
| Redipor | Analytichem USA, Inc. | 27 |
| HardyCHROM | Hardy Diagnostics | 11 |
| AnaeroGRO | Hardy Diagnostics | 5 |
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Showing 12 of 97. All products under Culture Media, Selective And Differential
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.