STAT-Site WB Dual Analyte Measurement System - The EKF Diagnostics STAT-Site WB Dual Analyte - STANBIO LABORATORY, L.P.

Duns Number:045361136

Device Description: The EKF Diagnostics STAT-Site WB Dual Analyte Measurement System is intended for the quant The EKF Diagnostics STAT-Site WB Dual Analyte Measurement System is intended for the quantitative measurement of B-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger, and from venous whole blood, and for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and from venous, and neonatal whole blood.The EKF Diagnostics STAT-Site WB Dual Analyte Measurement System is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.The system should not be used for the diagnosis of or screening for diabetes.The EKF Diagnostics STAT-Site WB B-Ketone Test Strips are for use with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System to quantitatively measure B-ketone in fresh capillary whole blood samples drawn from the fingertips and from venous whole blood.EKF Diagnostics STAT-Site WB Blood Glucose Test Strips are for use with EKF Diagnostics STAT-Site WB Dual Analyte Measurement System to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, and from venous and neonatal whole blood.

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More Product Details

Catalog Number

7000-001

Brand Name

STAT-Site WB Dual Analyte Measurement System

Version/Model Number

7000-001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Device Record Status

Public Device Record Key

c32329bd-4811-4473-8df2-bcf8dea7b3ca

Public Version Date

November 26, 2019

Public Version Number

1

DI Record Publish Date

November 18, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STANBIO LABORATORY, L.P." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 69
2 A medical device with a moderate to high risk that requires special controls. 86