Cyclosporine C2 Control 202

GUDID 00856743007055

MORE DIAGNOSTICS Cyclosporine C2 Controls are assayed quality control materials for monitoring and evaluating precision and accuracy of quantitative cyclosporine measurements in whole blood.

MORE DIAGNOSTICS INC

Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control

• Primary Device ID: 00856743007055
• NIH Device Record Key: 56c07116-5c84-48aa-98de-5d257a0fe0d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cyclosporine C2 Control
• Version Model Number: 202
• Catalog Number: 202
• 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: (800) 758-0978
• 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	00856743007055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932662

FDA Product Code

• LAS: Drug Specific Control Materials

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: 2018-04-03

Devices Manufactured by MORE DIAGNOSTICS INC

• 00856743007277 - EV/TAC/CsA Control: 2019-08-14 MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of eve
• 00856743007284 - EV/TAC/CsA Control: 2019-08-14 MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of eve
• 00856743007291 - EV/TAC/CsA Control: 2019-08-14 MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of eve
• 00856743007307 - EV/TAC/CsA Control: 2019-08-14 MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of eve
• 00856743007017 - Cardiac Marker Control: 2018-07-06 MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, tro
• 00856743007024 - Cardiac Control Marker: 2018-07-06 MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, tro
• 00856743007031 - Cardiac Marker Control: 2018-07-06 MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, tro
• 00856743007048 - Cardiac Marker Control: 2018-07-06 MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, tro