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STAT-Site WB Dual Analyte Measurement System

FDA UDI

Class II (US FDA UDI)

by Stanbio Laboratory, L.p.

Identity

Trade Name
STAT-Site WB Dual Analyte Measurement System FDA UDI
Generic Name
Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
Device Name
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. FDA UDI
Model / Reference
7000-001 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
7000-001 FDA UDI
Primary DI / UDI-DI
00657498002179 FDA UDI
FDA Product Code
NBW FDA UDI
GMDN Term
Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple clinical chemistry analyte monitoring system IVD, home-use

STAT-Site WB Dual Analyte Measurement System by Stanbio Laboratory, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry analyte monitoring system IVD, home-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stanbio Laboratory, L.p.

Sources (1)

  • FDA UDI c32329bd-4811-4473-8df2-bcf8dea7b3ca 36 fields · synced May 30, 2026