Detector UA 5
Catalogue number IDU-5OB, listed by Immunostics, Inc., United States, under Blood, Occult, Colorimetric, In Urine. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (2), Jilin (1), Guangxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
Record
| Listed by | Immunostics, Inc., United States |
|---|---|
| FDA product code | JIO |
| Device type | Blood, Occult, Colorimetric, In Urine |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6550 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K970250 |
| Record published | 2016-09-25 |
| Record revised | 2025-03-31 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C; Special storage condition: Store at room temperature |
| Packaging | Pack of 24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IDU-5OB | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 10 |
| Teco Diagnostics | Teco Diagnostics | 6 |
| Clinitek Advantus® Analyzer | Siemens Healthcare Diagnostics Inc | 1 |
| Urisys 2400 Cassette | Roche Diagnostics Gmbh | 1 |
| Urisys 2400 Calibration strip | Roche Diagnostics Gmbh | 1 |
| Aimstrip US-4 | Germaine Laboratories, Inc. | 1 |
| Urine Reagent Strips, 5-parameter | LW Scientific, Inc. | 1 |
| Labstix® Reagent Strips | Siemens Healthcare Diagnostics Inc | 1 |
| Blood, Occult, Colorimetric, In Urine | Remel, Inc. | 1 |
| McKesson | Mckesson Medical-Surgical Inc. | 1 |
| Urine Chemistry Strips | Urit Medical Electronic Co., Ltd. | 1 |
| Mission U120 Smart Urine Analyzer | Acon Laboratories, Inc. | 1 |
Showing 12 of 17. All products under Blood, Occult, Colorimetric, In Urine
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.