Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-47136487609BKT3J
- Basic UDI-DI Code
- B-47136487609BKT3J
- Reference
- S5640894
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The KETOSURE™POC Blood Ketone Test Strip should only be used with the KETOSURE™ POC meter to quantitatively measure blood ketone in venous whole blood or capillary whole blood. The KETOSURE™ POC Blood Ketone Test Strip is plasma-calibrated for easy comparison to lab results, and 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. The KETOSURE™ POC Blood Ketone Test Strip is not intended for neonatal use or for diagnosis ketone related illness such as diabetic ketoacidosis (DKA).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060110 | KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS) |
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