INFINITY™ Normal Control Solution

GUDID 00885502004004

U.S. DIAGNOSTICS INC.

Glucose IVD, control Glucose IVD, control

• Primary Device ID: 00885502004004
• NIH Device Record Key: 2ea19080-ef39-4760-b1c1-753754c77c5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INFINITY™ Normal Control Solution
• Version Model Number: IGM-0024
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885502004004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082201

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: 2018-10-25
• Device Publish Date: 2018-09-24

Devices Manufactured by U.S. DIAGNOSTICS INC.

• 00885502004004 - INFINITY™ Normal Control Solution: 2018-10-25
• 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
• 00885502016038 - EasyGluco™ High Control Solution: 2018-10-25
• 00885502000006 - INFINITY™ Starter Kit: 2018-07-06
• 00885502000037 - EasyGluco™G2 Starter Kit: 2018-07-06