plusMED fasTTest
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Basic Information
- Primary DI
- D-T05D5900002SNLC
- Basic UDI-DI Code
- B-T05D5900002SNLC
- Reference
- pM-100_CS_Low
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Tyson Bioresearch, Inc.
Additional Description
The plusMED fasTTest Control Solution is a desired aqueous glucose solution with small amounts of non-reactive ingredients and food coloring for verifying the accuracy of the entire plusMED fasTTest Blood Glucose Monitoring System. The control solutions are used to check the performance of the plusMED fasTTest meter, plusMED fasTTest test strips, and your testing technique. The plusMED fasTTest Blood Glucose Monitoring System is intended for use in the home self-testing and in professional settings to monitor blood glucose levels.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | C-02-1073-797-22 | Eurofins Electric & Electronics Finland Oy | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).