Soludiab
Basic Information
- Primary DI
- D-T05H7990073KNX5
- Basic UDI-DI Code
- B-T05H7990073KNX5
- Reference
- LGLMV-02
- 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 LGLMV-02 Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in venous blood and fresh capillary whole blood. Capillary whole blood may be drawn from the fingertip, palm and the forearm. It is not intended for neonatal testing. The BRLMV-BT-01 Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The LGLMV-02 Blood Glucose Monitoring System is intended for use at home (Over the Counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady state blood glucose conditions.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060102 | BLOOD GLUCOSE METERS |
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).