True Metrix
Relion TRUE METRIX Self Monitoring Blood Glucose Test Strips - 50ct Test Strips
5manufacturers in China registered for this device type
15catalogue numbers in this listing
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 | Trividia Health, Inc., United States |
|---|---|
| FDA product code | LFR |
| Device type | Glucose Dehydrogenase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-20 |
| Record revised | 2025-11-03 (version 18) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 40 to 86 °F |
| Packaging | Case of 24, box, box of 2, case of 12, case of 360, case of 40 |
| Distribution end date | 2020-05-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS – 25 Test Strips | 25 | In distribution | |
| TRUE METRIX Self Monitoring Blood Glucose Meter | In distribution | ||
| TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER | In distribution | ||
| TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS – 10 Test Strips | 10 | In distribution | |
| TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM | In distribution | ||
| TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS – 50 Test Strips | 50 | In distribution | |
| TRUE METRIX Self Monitoring Blood Glucose Meter | In distribution | ||
| TRUE METRIX Self Monitoring Blood Glucose Test Strips | 50 | In distribution | |
| TRUE METRIX Self Monitoring Blood Glucose Meter | In distribution | ||
| TRUE METRIX Self Monitoring Blood Glucose Meter | In distribution | ||
| TRUE METRIX Self Monitoring Blood Glucose Meter | Withdrawn | ||
| TRUE METRIX self monitoring blood glucose meter | Withdrawn | ||
| TRUE METRIX PRE-PACK | Withdrawn | ||
| TRUE METRIX PRE-PACK | Withdrawn | ||
| TRUE METRIX PRE-PACK – USE ONLY FOR MEDICARE AND MEDICAID | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Precision Xtra | Abbott Diabetes Care Limited | 5 |
Showing 12 of 124. All products under Glucose Dehydrogenase, Glucose
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Trividia Health, Inc. | UDI-DI | 2025-10-07 | Class II | Device Design | Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management. | 601 units |
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.