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STAT-Site WB B-Ketone Test Strips

FDA UDI

Class I (US FDA UDI)

by Stanbio Laboratory, L.p.

Identity

Trade Name
STAT-Site WB B-Ketone Test Strips FDA UDI
Generic Name
Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
Device Name
The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary and venous whole blood samples. It should not be used for the diagnosis of or screening for diabetes, nor for use on neonates. FDA UDI
Model / Reference
7020-100 FDA UDI
Description
The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary and venous whole blood samples. It should not be used for the diagnosis of or screening for diabetes, nor for use on neonates. FDA UDI

Identifiers

Catalog Number
7020-100 FDA UDI
Primary DI / UDI-DI
00657498002254 FDA UDI
FDA Product Code
JIN FDA UDI
GMDN Term
Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1435 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

STAT-Site WB B-Ketone Test Strips by Stanbio Laboratory, L.p. — Class I — 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 fa94ca3c-810c-4c74-a766-945797f83c1a 36 fields · synced May 31, 2026