OneTouch Verio Reflect
OneTouch Verio Reflect is a blood-glucose monitoring system for individual self-testing using fingertip capillary blood. Its meter reads an electrical current generated in a compatible…
OneTouch Verio Reflect is a blood-glucose monitoring system for individual self-testing using fingertip capillary blood. Its meter reads an electrical current generated in a compatible OneTouch Verio test strip.
The strip uses an electrochemical reaction with FAD-dependent glucose dehydrogenase. The meter converts the measured current into a plasma-equivalent glucose result, using a minimum blood sample of 0.4 microlitres and a five-second test time.
Listed Item
OneTouch Verio Reflect Blood Glucose Monitoring System. Value Pack Kit
System Components and Display
The system includes the meter, test strips, control solutions, lancing device and sterile lancets. Display tools include a dynamic range indicator, test tracker, averages and tagging features. It is intended for a single person’s monitoring and is not a diabetes screening or diagnostic system.
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 | Lifescan Europe Gmbh, Switzerland |
|---|---|
| FDA product code | NBW |
| Device type | System, Test, Blood Glucose, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K193475 |
| Record published | 2021-09-25 |
| Record revised | 2025-12-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 41 to 86 °F; Handling environment temperature 43 to 111 °F; Handling environment humidity 10 to 90 °F; Special storage condition: keep away from direct sunlight and heat |
| Packaging | Shipper case of 10, shipper container of 32, shipper of 4, shipper container of 10, shipper case of 4, shipper of 10 |
| Sizes | Needle gauge 30 G |
| Distribution end date | 2025-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 024-237 | In distribution | |
| 024-266 | In distribution | |
| 023-900 | In distribution | |
| 023-927 | Needle Gauge 30 G | In distribution |
| 024-369 | In distribution | |
| 023-899 | Needle Gauge 30 G | Withdrawn |
| 023-878 | Withdrawn |
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 |
|---|---|
| K193475 | 2020-02-14 |
| K151611 | 2015-12-14 |
| K150214 | 2015-07-31 |
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.