VITROS Chemistry Products TDM Performance Verifier II

VITROS Chemistry Products TDM Performance Verifier II
VITROS - 1792357

A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DIF

Device Name: Drug Mixture Control Materials

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: TX

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.3280

Third Party Flag: N

Medical Specialty: TX

Device Id: 10758750000067

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

Device Id: 20758750000064

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10758750000067

Package Quantity: 100

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case