3 catalogue numbers from 020-994, listed by LifeScan U.S. LLC, United States, under Glucose Oxidase, Glucose. 8 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for OneTouch Ultra Blue | Listed by | LifeScan U.S. LLC, United States |
| FDA product code | CGA |
| Device type | Glucose Oxidase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2017-09-13 |
| Record revised | 2026-04-13 (version 7) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 86 °F; Special storage condition: Do Not Refrigerate; Special storage condition: Store your test strips in their original vial only.; Special storage condition: Use within 6 months of opening test strip vial. |
| Packaging | Shipper case of 24 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
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.