TRICYCLICS LEVEL 2 V2
TRICYCLICS LEVEL 2 V2 - TCA L2 V2 S 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 antidepressant drugs from multiple classes [e.g., tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), tetracyclic antidepressants (TeCAs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)] in a clinical specimen.
Environmental Conditions
- -10.00
- N/A
Device Sizes
- Total Volume: 1 Milliliter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 Identifiers
Device Id: B800TCAL2V2SMAYO5
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B800TCAL2V2SMAYO0
Package Quantity: 81
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: B800TCAL2V2SMAYO0
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
