Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-47136487609BU94
- Basic UDI-DI Code
- B-47136487609BU94
- Reference
- S5400044
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The KETOSURE POC blood ketone monitoring system is intended to quantitatively measure blood ketone level in venous whole blood or fresh capillary whole blood drawn from fingertips. The KETOSUR POC blood ketone monitoring system is intended for testing outside the body (in vitro diagnostic use). It is intended for use by healthcare professionals in laboratories such as physician office laboratories, clinics, and hospitals, as an aid in monitoring blood ketone level in diabetes mellitus. It is not indicated for diagnosis or screening of diabetes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201069080 | VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES |
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