B-Ketone Control Solution 7024-204

GUDID 00657498002278

Our B-Ketone Control Solution is intended for use to ensure your meter and test strips are working together properly. Use with EKF Diagnostics' B-Ketone Test Strips only.

STANBIO LABORATORY, L.P.

Glucose/ketone monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use

• Primary Device ID: 00657498002278
• NIH Device Record Key: 797ee340-6932-4b43-95c7-423fbd178bf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B-Ketone Control Solution
• Version Model Number: 7024-204
• Catalog Number: 7024-204
• Company DUNS: 045361136
• Company Name: STANBIO LABORATORY, L.P.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00657498002278 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-26
• Device Publish Date: 2019-11-18

Devices Manufactured by STANBIO LABORATORY, L.P.

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• 00657498002322 - HGB Controls - Low: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498002339 - HGB Controls - Low: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498002346 - HGB Controls - Normal: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498002353 - HGB Controls - Normal: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498002360 - HGB Controls - High: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498002377 - HGB Controls - High: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498001806 - Standard 1: 2020-03-02 To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas® Chemistry Sy