Teco Diagnostics
URS-10 100 Finished Kit for TC-Thunderbolt
8manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
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 | Teco Diagnostics, United States |
|---|---|
| FDA product code | JRE |
| Device type | Refractometer For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K141289 |
| Record published | 2017-01-05 |
| Record revised | 2022-11-28 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| URS-4S-100 GENERIC | In distribution | |
| URS-10-100 GRAY BOTTLE | In distribution | |
| URS-10-100 TC-THUNDERBOLT | In distribution | |
| URS-4S-100 BOTTLE | In distribution | |
| URS-4S-100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Detector UA 10 | Immunostics, 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K954977 | 1996-03-11 |
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.