Phenytoin Master Curve Material - CENTAUR

Phenytoin Master Curve Material
ADVIA Centaur® PHTN MCM - 10311390

Device Description

A material which is used to verify the performance of 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.

Environmental Conditions

Special Storage Condition, Specify

Store Upright, Protect from Light, Do not freeze, Resuspend.

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 00630414121758

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

Phenytoin Master Curve Material - CENTAUR - CONS