- Physicians Office Resource

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 Identifiers

Device 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

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