One Step Drug Screen Test Card (COC300/AMP1000/mAMP1000/THC50/MTD300/OPI2000/PCP25/BAR300/BZO300/TCA1000)
NA - DOA-1104
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
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: LCM
Device Name: Enzyme Immunoassay, Phencyclidine
Device Class: U
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: 1
Implant Flag: N
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
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: DKZ
Device Name: Enzyme Immunoassay, Amphetamine
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: 862.3100
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
Code: DJC
Device Name: Thin Layer 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: 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: DIO
Device Name: Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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
Device IdentifiersDevice Id: 10815845020840
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
Device Id: 00815845020843
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