SureStepTM Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000) - DTC-101-a-Sgl
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
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: LFG
Device Name: Radioimmunoassay, Tricyclic Antidepressant Drugs
Device Class: 2
Physical State: The device may be composed of a collection apparatus and / or measurement assay.
Definition: Intended to measure any of the tricyclic antidepressant drugs in serum or urine.
Submission Type ID: 1
Review Panel: TX
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Serum or urine are collected and analyzed for the presence of antidepressant drugs.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Serum or urine.
Regulation Number: 862.3910
Third Party Flag: Y
Medical Specialty: TX
Device IdentifiersDevice Id: 10810124273085
Device Type: Unit of Use
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
Device Id: 00810124273088
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