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Blood Glucose Test Strips - 35 Test Strips (per bottle) - sold in a carton of 2 bottles (70 test strips total).
5manufacturers in China registered for this device type
6catalogue 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 | Ascensia Diabetes Care US Inc., United States |
|---|---|
| FDA product code | LFR |
| Device type | Glucose Dehydrogenase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K121190 |
| Record published | 2017-11-03 |
| Record revised | 2025-04-01 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store test strips in their original bottle only. Always close the lid immediately and tightly after removing a test stri; Handling environment humidity 10 to 80 % RH; Storage environment temperature 41 to 86 °F |
| Packaging | Case of 24, carton, case of 12, carton of 2, shipper / speed pack of 4 |
| Distribution end date | 2024-03-29 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 7278 | 35 | In distribution | |
| 7311 | 50 | In distribution | |
| 7310 | 25 | In distribution | |
| 7277 | 35 | In distribution | |
| 7313 | 10 | In distribution | |
| 7308 | 50 | Withdrawn |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 |
| 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 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Ascensia Diabetes Care US Inc. | 510(k) number | 2023-05-19 | Class II | Process control | Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters distributed in the United States were packaged into the meter | 2,888 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.