Detector UA 10
Catalogue number IDU-10, listed by Immunostics, Inc., United States, under Refractometer For Clinical Use. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (2), Jilin (2), Guangxi (1). 2 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 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
| Shanghai Youding International Trade Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 17 |
| Changchun LYZ Technology Co., Ltd. | Changchun | Jilin | Manufacturer | 16 |
Record
| Listed by | Immunostics, Inc., United States |
|---|---|
| FDA product code | JRE |
| Device type | Refractometer For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K970250 |
| Record published | 2016-09-26 |
| 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-10 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Teco Diagnostics | Teco Diagnostics | 5 |
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 2 |
| Accustrip 10-Parameter Urine Reagent Strip | Jant Pharmacal Corp. | 1 |
| Accustrip URS Strips + Reader | Jant Pharmacal Corp. | 1 |
| PC | Allied Medical LLC | 1 |
| Urine Reagent Strips, 10-parameter | LW Scientific, Inc. | 1 |
| Reichert® Digital USG-Chek | Reichert Inc. | 1 |
| Clinical Refractometers Reichert® Digital Clinic-Chek | Reichert Inc. | 1 |
| Multistix® 9 Reagent Strips | Siemens Healthcare Diagnostics Inc | 1 |
| Accutest | Jant Pharmacal Corp. | 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.