Mycophenolic Acid Flex® reagent cartridge, 80 tests

Mycophenolic Acid Flex® reagent cartridge, 80 tests
Dimension® Flex® reagent cartridge MPAT - 10706859

A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug mycophenolate (e.g., CellCept) in a clinical specimen, using a nephelometry/turbidimetry method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OAV

Device Name: Mycophenolic Acid Test System

Device Class: 2

Physical State: Liquid

Definition: An in vitro diagnostic reagent system intended for use in the quantitative determination of total mycophenolic acid in human serum or plasma as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients.

Submission Type ID: 1

Review Panel: TX

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Enzyme-mimicking assay with MPA concentration inversely proportional to the formation of NADH.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Renal and Cardiac Transplant Patients

Regulation Number: 862.3840

Third Party Flag: Y

Medical Specialty: TX

Device Id: 00842768036217

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A