AccuDiag ™ 3149-18

GUDID 00894175000893

AccuDiag ™ T4 ELISA Kit For the quantitative determination of the Total Thyroxine (T4) concentration in human serum.

Diagnostic Automation, Inc.

Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00894175000893
• NIH Device Record Key: da176cf4-7cac-487f-b240-5ccf0c846403
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuDiag ™
• Version Model Number: DACD3149-18
• Catalog Number: 3149-18
• Company DUNS: 878252071
• Company Name: Diagnostic Automation, 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: true
• 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: false

Customer Support Contacts

• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894175000893 [Primary]

FDA Product Code

• KLI: Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

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: 2023-06-22
• Device Publish Date: 2023-06-14

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