23-300-102
Vidan™ Diagnostics Lucidplus™ Beta-Hydroxybutyrate (BHB) Test Strips
Manufacturer: Vidan™ Diagnostics
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Certifications/Compliance
FDA 510(k)
CPT Code
82010
Clia Complexity
Waived
Format
Test Strips
Type
Quantitative Determination of Beta-Hydroxybutyrate in Whole Blood
For Use With (Application)
Lucidplus BHB Plus Glucose Monitoring System
Packaging Type
50 test strips per kit
Range
0.1 to 8.0 mmol/L
Content And Storage
Room Temperature
CE Marker
No
Detectable Analytes
beta-hydroxybutyrate
Sample Type
Whole Blood (Venous/Capillary)
Formulation
Beta-hydroxybutyrate Dehydrogenase/Biosensor
Includes
BHB Test Strips, 50 count, (1) code chip and (1) package insert
Quantity
1 Kit
Sample Size
0.8 μL
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Description
- Methodology (Biosensor), Beta-hydroxybutyrate (BHB) Kit Size, 50 tests per kit Sample size, 0.8 μL Reportable range, 0.1 to 8.0 mmol/L Time to result, approximately 10 seconds Hematocrit range, 10 to 70% Precision, SD<0.1mmol/L ≤1mmol/L: CV<7.5% at >1mmol/L FDA 510(k), CLIA Waived Expiration :16 months from date of manufacturing