MultiSure GK
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- D-47136487612AKT27
- Basic UDI-DI Code
- B-47136487612AKT27
- Reference
- S5640465, S5640466
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The MultiSure GK Blood Ketone Test Strip is to be used with the Multisure GK blood glucose and ketone meter to quantitatively measure blood ketone in venous whole blood or capillary whole blood. The MultiSure GK Blood Ketone Test Strip is plasma-calibrated for easy comparison to lab results. It is intended for self-testing by people with diabetes or for healthcare professionals use. It is not indicated for the diagnosis or screening of diabetes or for neonate use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060110 | KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2100077-1 | TÜV Rheinland LGA Products GmbH | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).