Control™ Test Strips IGM-G3-203

GUDID 10885502002045

U.S. DIAGNOSTICS INC.

Glucose IVD, kit, electrometry

• Primary Device ID: 10885502002045
• NIH Device Record Key: cf0b0987-278b-4d1a-a431-012aa8f364b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control™ Test Strips
• Version Model Number: IGM-0009
• Catalog Number: IGM-G3-203
• Company DUNS: 828116728
• Company Name: U.S. DIAGNOSTICS INC.
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net

Device Dimensions

• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885502002048 [Package]; Package: [2 Units]; In Commercial Distribution
GS1	10885502002045 [Primary]

FDA Product Code

• CGA: Glucose Oxidase, Glucose

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-11-11
• Device Publish Date: 2017-10-26

Devices Manufactured by U.S. DIAGNOSTICS INC.

• 10885502002007 - INFINITY™ Test Strips: 2024-11-11
• 00885502002031 - EasyGluco™G2 Test Strips: 2024-11-11
• 10885502002045 - Control™ Test Strips: 2024-11-11
• 10885502002045 - Control™ Test Strips: 2024-11-11
• 00885502004004 - INFINITY™ Normal Control Solution: 2018-10-25
• 00885502004035 - EasyGluco™ Normal Control Solution: 2018-10-25
• 00885502015000 - INFINITY™ Low Control Solution: 2018-10-25
• 00885502015031 - EasyGluco™ Low Control Solution: 2018-10-25
• 00885502016007 - INFINITY™ High Control Solution: 2018-10-25