Tyson Bio HT100-B Blood Glucose Test Strip, 50t
The Tyson Bio HT100-B test strip is used with the matching glucose meter to measure glucose in fresh capillary whole blood. The system supports home self-testing by one person with diabetes…
The Tyson Bio HT100-B test strip is used with the matching glucose meter to measure glucose in fresh capillary whole blood. The system supports home self-testing by one person with diabetes to monitor diabetes control.
The strip uses an electrochemical biosensor with glucose dehydrogenase. Blood samples may come from the fingertip, palm or forearm, but palm and forearm testing is limited to steady-state conditions when glucose is not changing rapidly.
Testing Boundaries
The strip is used only with the HT100-B meter and compatible control solution. The system is not intended for diabetes diagnosis or screening, neonatal testing or sharing between patients.
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (4), Zhejiang (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Altek Medical (kunshan) limited | Kunshan Free Trade Zone | Jiangsu | Contract manufacturer | 2 |
| Dongguan Kaifa Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 20. All 20 manufacturers in China registered for System, Test, Blood Glucose, Over The Counter
Record
| Listed by | Tyson Bioresearch, Inc., Taiwan |
|---|---|
| FDA product code | NBW |
| Device type | System, Test, Blood Glucose, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K170079 |
| Record published | 2020-08-11 |
| Record revised | 2026-04-13 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 280, pack of 560, pack of 500, pack of 250 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HT100-B | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| True Metrix | Trividia Health, Inc. | 40 |
| Fora | Fora Care Inc. | 31 |
| True Metrix AIR | Trividia Health, Inc. | 21 |
| GE | Bionime Corporation | 21 |
| TRUEtrack | Trividia Health, Inc. | 17 |
| Medline | Medline Industries, Inc. | 15 |
| AgaMatrix | Agamatrix | 15 |
| Tenovi | Tenovi Co | 13 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 11 |
| Accu-Chek Guide | Roche Diagnostics Operations | 10 |
| Curaplex | Bound Tree Medical, LLC | 10 |
| OneTouch Verio | Lifescan Europe Gmbh | 10 |
Showing 12 of 476. All products under System, Test, Blood Glucose, Over The Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182046 | 2018-11-30 |
| K182047 | 2018-11-29 |
| K170079 | 2017-10-06 |
| K123087 | 2013-06-18 |
| K112916 | 2012-08-21 |
| K101543 | 2011-08-30 |
| K090629 | 2009-06-04 |
| K081726 | 2008-08-26 |
| K072854 | 2008-06-30 |
| K073492 | 2008-04-08 |
| K072441 | 2008-03-25 |
| K062829 | 2006-10-10 |
| K052818 | 2006-06-16 |
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.