FDA.reportPublic FDA data

Amphetamine-specific IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of a specific amphetamine in a clinical specimen.
GUDID devices
6
Last updated
2020-10-05 06:30:13

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00811727018052Pointe Ecstasy (MDMA) Control (375 ng/mL) Level 1HORIBA INSTRUMENTS INCORPORATED60-EC0334-52020-09-25
00811727018069Pointe Ecstasy (MDMA) Control (625 ng/mL) Level 2HORIBA INSTRUMENTS INCORPORATED60-EC0336-52020-09-25
00840937103562ImmunalysisIMMUNALYSIS CORPC309UR-5-2-10002016-08-31
00840937103586ImmunalysisIMMUNALYSIS CORPC309UR-5-2-5002016-08-31
B076S0046B0Oral Fluid Amphetamine Control, Level 1 ControlLIN-ZHI INTERNATIONAL, INC.S0046b2016-07-05
B076S0047B0Oral Fluid Amphetamine Control, Level 2 ControlLIN-ZHI INTERNATIONAL, INC.S0047b2016-07-05