Rap/Tac/CsA Control 290-2

GUDID 00856743007222

MORE DIAGNOSTICS Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of rapamycin, tacrolimus, and cyclosporine.

MORE DIAGNOSTICS INC

Multiple immunosuppressant therapeutic drug monitoring IVD, control

• Primary Device ID: 00856743007222
• NIH Device Record Key: 377aa146-53aa-4876-9915-8cb61bd65825
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rap/Tac/CsA Control
• Version Model Number: 290-2
• Catalog Number: 290-2
• Company DUNS: 829978451
• Company Name: MORE 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: true
• 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: 18007580978
• Email: info@morediagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -14 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856743007222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050125

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-31

On-Brand Devices [Rap/Tac/CsA Control]

• 00856743007239: MORE DIAGNOSTICS Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control p
• 00856743007222: MORE DIAGNOSTICS Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control p
• 00856743007215: MORE DIAGNOSTICS Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control p
• 00856743007208: MORE DIAGNOSTICS Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control p
• 00856743007192: MORE DIAGNOSTICS Rap/Tac/CsA Control is intended to be used as a whole blood precision control p
• 00856743007185: MORE DIAGNOSTICS Rap/Tac/CsA Control is intended to be used as a whole blood precision control p
• 00856743007178: MORE DIAGNOSTICS Rap/Tac/CsA Control is intended to be used as a whole blood precision control p
• 00856743007161: MORE DIAGNOSTICS Rap/Tac/CsA Control is intended to be used as a whole blood precision control p
• 00856743007154: MORE DIAGNOSTICS Rap/Tac/CsA Control is intended to be used as a whole blood precision control p
• 00856743007147: MORE DIAGNOSTICS Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control p
• 00856743007130: MORE DIAGNOSTICS Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control p
• 00856743007123: MORE DIAGNOSTICS Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control p