Syva® Emit® tox™ Tricyclic Antidepressants Calibrator/Controls, 3 levels

Syva® Emit® tox™ Tricyclic Antidepressants Calibrator/Controls, 3 levels
Syva® Emit® tox™ Tricyclic Antidepressants Calibrator/Controls - 10445390

A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.

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

Device Id: 00842768014321

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