Triage TOX Drug Screen, 94600
Triage - 94600
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen, using a fluorescent immunoassay method.
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: LAF
Device Name: Gas Chromatography, Methamphetamine
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 862.3610
Third Party Flag: Y
Medical Specialty: TX
Code: KHO
Device Name: Fluorometer, For Clinical Use
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
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: 862.2560
Third Party Flag: N
Medical Specialty: CH
Code: DIS
Device Name: Enzyme Immunoassay, Barbiturate
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 862.3150
Third Party Flag: Y
Medical Specialty: TX
Code: JXM
Device Name: Enzyme Immunoassay, Benzodiazepine
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 862.3170
Third Party Flag: Y
Medical Specialty: TX
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
Code: LDJ
Device Name: Enzyme Immunoassay, Cannabinoids
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 862.3870
Third Party Flag: Y
Medical Specialty: TX
Code: JXO
Device Name: Enzyme Immunoassay, Cocaine
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 862.3250
Third Party Flag: Y
Medical Specialty: TX
Code: DJR
Device Name: Enzyme Immunoassay, Methadone
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 862.3620
Third Party Flag: Y
Medical Specialty: TX
Code: DJG
Device Name: Enzyme Immunoassay, Opiates
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 862.3650
Third Party Flag: Y
Medical Specialty: TX
Device IdentifiersDevice Id: 30014613338109
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