Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System
Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System is an in vitro diagnostic device used to automate the urine chemistry analysis using TC-Thunderbolt URS-10 strips. It…
Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System is an in vitro diagnostic device used to automate the urine chemistry analysis using TC-Thunderbolt URS-10 strips. It produces semi-quantitative results of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine. TC-Thunderbolt URS-10 strips are intended for use only with the TC-Thunderbolt Automated Urine Analyzer System; they are not intended for manual visual reading. This device is for clinical laboratory use only. This device is not for point-of-care use. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function.
Who Else Makes It
Concentrated in Jilin (6), Zhejiang (2), Guangxi (1). 5 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 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
| Changchun LYZ Technology Co., Ltd. | Changchun | Jilin | Manufacturer | 16 |
Showing 12 of 14. All 14 manufacturers in China registered for Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Record
| Listed by | Teco Diagnostics, United States |
|---|---|
| FDA product code | JIR |
| Device type | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1645 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K141289 |
| Record published | 2024-06-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 5 to 40 °C; Handling environment humidity 30 to 80 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TC-Thunderbolt | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 12 |
| Teco Diagnostics | Teco Diagnostics | 5 |
| Rapid Response | Btnx Inc. | 3 |
| Cybow P | DFI Co., Ltd. | 2 |
| Total Protein (UP) | Randox Laboratories Limited | 2 |
| Medline | Medline Industries, Inc. | 2 |
| Tinaquant Albumin | Roche Diagnostics Gmbh | 2 |
| Micro-albumin Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Multistix® 9 SG Reagent Strips | Siemens Healthcare Diagnostics Inc | 1 |
| Chemstrip Micral Urine Test Strips | Roche Diagnostics Gmbh | 1 |
| Micro Protein (CSF/Urine) LiquiColor® | Stanbio Laboratory, L.P. | 1 |
| Uri-Trak 120 M Urine Analyzer | Stanbio Laboratory, L.P. | 1 |
Showing 12 of 36. All products under Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K061419 | 2007-01-26 |
| K955438 | 1996-01-29 |
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.