Blood Glucose Control Solution 7014-204

GUDID 00657498002261

Blood Glucose Control Solution is intended for use with EKF Diagnostic’s Blood Glucose Test Strip. It is used to check that the meter and test strips are working together properly. It is important to do control solution tests routinely to ensure getting accurate results.

STANBIO LABORATORY, L.P.

Glucose/ketone monitoring system IVD, home-use

• Primary Device ID: 00657498002261
• NIH Device Record Key: d7e3650d-5c8a-42c0-8cb4-2d9e543edbd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood Glucose Control Solution
• Version Model Number: 7014-204
• Catalog Number: 7014-204
• 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	00657498002261 [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

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• 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