GL GoodLife Blood Glucose Test Strip
The GoodLife Blood Glucose Test Strip is used with the GoodLife AC-302 meter to measure glucose in fresh capillary whole blood from the fingertip. It supports home monitoring by one person…
The GoodLife Blood Glucose Test Strip is used with the GoodLife AC-302 meter to measure glucose in fresh capillary whole blood from the fingertip. It supports home monitoring by one person with diabetes. It is not intended for diagnosing or screening for diabetes, or for neonatal testing.
Blood enters the strip’s reaction zone and mixes with its chemical reagents. The reaction produces an electrical current proportional to the glucose in the sample. The connected meter measures this current and calculates the blood glucose result for display.
Listed Item
GL GoodLife Blood Glucose Test Strip(AC-302)
Compatible Testing
The strip is part of the GoodLife AC system and is used with its compatible meter. GoodLife glucose control solution can be used with the strip and meter to check their combined performance.
Who Else Makes It
Concentrated in Tianjin (2), Guangdong (2), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
Record
| Listed by | HMD Biomedical, Inc., Taiwan |
|---|---|
| FDA product code | LFR |
| Device type | Glucose Dehydrogenase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Contract manufacturer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
| 510(k) | K113307 |
| Record published | 2016-12-09 |
| Record revised | 2026-04-13 (version 5) |
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, manufacturing date, serial number |
| Packaging | Pack of 400 |
| Distribution end date | 2016-12-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AC-11 AC302 (vial) | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| True Metrix | Trividia Health, Inc. | 15 |
| Contour® | Ascensia Diabetes Care US Inc. | 10 |
| Fora | Fora Care Inc. | 9 |
| Contour® Next ONE | Ascensia Diabetes Care US Inc. | 9 |
| True Metrix GO | Trividia Health, Inc. | 8 |
| OneTouch Verio | Lifescan Europe Gmbh | 8 |
| Accu-Chek Aviva Plus | Roche Diagnostics Operations | 7 |
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
| Accu-Chek Guide | Roche Diagnostics Operations | 7 |
| Contour® Next | Ascensia Diabetes Care US Inc. | 6 |
| Accu-Chek Smart View | Roche Diagnostics Operations | 6 |
| FreeStyle Lite | Abbott Diabetes Care Limited | 5 |
Showing 12 of 124. All products under Glucose Dehydrogenase, Glucose
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121433 | 2013-02-14 |
| K113314 | 2012-11-09 |
| K113307 | 2012-07-27 |
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.