Ketone Urine Controls 4020-005

GUDID 00657498002162

Ketone Urine Controls is an assayed urine control intended for use in validating the precision of visual and analyzer reading of urinalysis for one or more of the following analytes: Ascorbic Acid, Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specify Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes and human Chorionic Gonadotropin.

STANBIO LABORATORY, L.P.

Multiple urine analyte IVD, control

• Primary Device ID: 00657498002162
• NIH Device Record Key: 27a29f80-cb5d-4b0d-8a4b-885af6a6aa5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ketone Urine Controls
• Version Model Number: 4020-005
• Catalog Number: 4020-005
• Company DUNS: 045361136
• Company Name: STANBIO LABORATORY, L.P.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00657498002162 [Primary]

FDA Product Code

• JJW: Urinalysis 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: 2019-03-19
• Device Publish Date: 2019-03-11

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