Accutest CLEAR TCA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit

Accutest CLEAR TCA Drug Screen Dip & Read. *CLIA
Accutest CLEAR TCA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit - DS309

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of tricyclic antidepressant drugs 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 Identifiers

Device Id: 10763924309914

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