OF QC 4 - QC 4 SMX-OF
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LAS
Device Name: Drug Specific 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 IdentifiersDevice Id: B80002942500080
Device Type: Primary
DeviceId Issuing Agency: HIBCC
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: B80002942500081
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B80002942500080
Package Quantity: 4
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: B80002942500082
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B80002942500080
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: B80002942500083
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B80002942500080
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: B80002942500086
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B80002942500080
Package Quantity: 25
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: B80002942500087
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B80002942500080
Package Quantity: 50
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: B80002942500088
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B80002942500080
Package Quantity: 100
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box