This product is intended for in vitro diagnostic use in the quality control of drug residue analysis on clinical chemistry systems. The Drug Controls are for the control of accuracy and precision.

This product is intended for in vitro diagnostic use in the quality control of drug residue analysis on clinical chemistry systems. The Drug Controls are for the control of accuracy and precision.
DRUG CONTROL - LEVEL 2 (TDM CONTROL 2) - HD1668

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple therapeutic drugs and drugs of abuse 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: 05055273203585

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