VLGR LEVEL 2 - VLGR 2 S F MAYO
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 multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) 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: B80002509000060
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: B80002509000061
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B80002509000060
Package Quantity: 4
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: B80002509000062
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B80002509000060
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: B80002509000063
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B80002509000060
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: B80002509000066
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B80002509000060
Package Quantity: 25
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: B80002509000067
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B80002509000060
Package Quantity: 50
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: B80002509000068
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B80002509000060
Package Quantity: 100
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: B80002509000069
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B80002509000060
Package Quantity: 81
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box