Phenytoin - CENTAUR - CAL - 2x2x2mL

Phenytoin
ADVIA Centaur® Systems, ACS:180® Systems PHTN Calibrator - 10311391

A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug phenytoin (e.g., dilantin) in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DIP

Device Name: Enzyme Immunoassay, Diphenylhydantoin

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 862.3350

Third Party Flag: Y

Medical Specialty: TX

Device Id: 00630414121765

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