NA

NA - DOA-1124-051

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.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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: JXN

Device Name: Enzyme Immunoassay, Propoxyphene

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: 862.3700

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: 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 Id: 10815845020918

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: 00815845020911

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