23-300-102

Vidan™ Diagnostics Lucidplus™ Beta-Hydroxybutyrate (BHB) Test Strips

Manufacturer: Vidan™ Diagnostics

The price for this product is unavailable. Please request a quote

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

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Vidan™ Diagnostics

23-300-102

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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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Vidan™ Diagnostics

23-300-103

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Certifications/Compliance:
FDA 510(k)

CPT Code:
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Clia Complexity:
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Format:
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Type:
Beta-Hydroxybutyrate Controls

For Use With (Application):
__

Packaging Type:
__

Range:
__

Content And Storage:
Room Temperature

CE Marker:
__

Detectable Analytes:
beta-hydroxybutyrate (BHB)

Sample Type:
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(1) bottle of Level 1 control and (1) bottle of Level 2 control

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Vidan™ Diagnostics

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(1) Dongle

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Vidan™ Diagnostics

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Certifications/Compliance:
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CPT Code:
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Clia Complexity:
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__

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__

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Content And Storage:
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Includes:
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