TysonBio AC200 Blood Glucose Test Strip, 10t
TysonBio AC200 test strips measure glucose in fresh capillary whole blood with the compatible AC200 meter. They are intended for home self-testing by one person with diabetes to monitor…
TysonBio AC200 test strips measure glucose in fresh capillary whole blood with the compatible AC200 meter. They are intended for home self-testing by one person with diabetes to monitor diabetes control. Blood samples may be taken from the fingertip, forearm or palm.
The strips use an electrochemical biosensor reaction based on glucose oxidase. The compatible meter measures the resulting signal to determine the glucose concentration. Only the specified AC200 strips and control solution are used with the AC200 system.
Sampling Limits
Forearm or palm testing should be performed only when glucose is stable. The system is not intended for diabetes diagnosis or screening, or for neonatal use.
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) | K101543 |
| Record published | 2019-03-11 |
| Record revised | 2026-04-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TysonBio AC200 | 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.