Teco Diagnostics
URS-10 100 (Russian) Finished KIT
5manufacturers in China registered for this device type
19catalogue numbers in this listing
8510(k) clearances naming this product code
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 | Teco Diagnostics, United States |
|---|---|
| FDA product code | JIL |
| Device type | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1340 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K970250 |
| Record published | 2018-01-04 |
| Record revised | 2022-11-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| 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-6L-100 | In distribution | |
| URS-10 100 Teco (RUSSIAN) | In distribution | |
| URS-2P-100 BOTTLE | In distribution | |
| URS-1G-100 | In distribution | |
| URS-1G-100 GENERIC | In distribution | |
| URS-10-100 BOTTLE | In distribution | |
| URS-2K-100 | In distribution | |
| URS-2K-100 BOTTLE | In distribution | |
| URS-1G-100 BOTTLE | In distribution | |
| URS-10-100 LABELED BOTTLE | In distribution | |
| URS-6-100 TECO FINISHED KIT | In distribution | |
| URS-2P-100 | In distribution | |
| URS-10-100 GENERIC | In distribution | |
| URS-10-100 SPANISH | In distribution | |
| URS-OBGYN-100 | In distribution | |
| URS-10-100 USA | In distribution | |
| URS-2P-100 GENERIC | In distribution | |
| URS-10-100 | In distribution | |
| URS-1G-100 GENERIC LABELED BOTTLE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 11 |
| McKesson | Mckesson Medical-Surgical Inc. | 5 |
| Henry Schein | Henry Schein, Inc. | 5 |
| Keto-Diastix® | Ascensia Diabetes Care US Inc. | 2 |
| Chemstrip 9 Urine Test Strips | Roche Diagnostics Gmbh | 2 |
| Medline | Medline Industries, Inc. | 2 |
| Aution MAX™ AX-4060 Analyzer | Arkray USA, Inc. | 2 |
| Diastix® | Ascensia Diabetes Care US Inc. | 2 |
| Aimstrip US-3 | Germaine Laboratories, Inc. | 1 |
| Urine Strips | Urit Medical Electronic Co., Ltd. | 1 |
| Chemstrip 10 MD Test Strips | Roche Diagnostics Gmbh | 1 |
| Urine Reagent Strips, 2-parameter; glucose, protein | LW Scientific, Inc. | 1 |
Showing 12 of 34. All products under Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160372 | 2016-07-22 |
| K141289 | 2015-07-24 |
| K131600 | 2014-05-29 |
| K101673 | 2011-02-04 |
| K020175 | 2002-03-21 |
| K970250 | 1997-04-08 |
| K942648 | 1995-03-24 |
| K940469 | 1994-09-09 |
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.