FDA.reportPublic FDA data

Methamphetamine-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 methamphetamine in a clinical specimen.
GUDID devices
11
Last updated
2020-10-05 06:30:12

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00811727018366Pointe Methamphetamine Control (375 ng/mL) Level 1HORIBA INSTRUMENTS INCORPORATED60-MP0714-52020-09-25
00811727018373Pointe Methamphetamine Control (625 ng/mL) Level 2HORIBA INSTRUMENTS INCORPORATED60-MP0716-52020-09-25
B07600470Amphetamines DAU Control, Level 1 ControlLIN-ZHI INTERNATIONAL, INC.00472016-07-05
B07600480Amphetamines DAU Control, Level 2 ControlLIN-ZHI INTERNATIONAL, INC.00482016-07-05
B07601070Amphetamines 500 DAU Control, Level 1 ControlLIN-ZHI INTERNATIONAL, INC.01072016-07-05
B07601080Amphetamines 500 DAU Control, Level 2 ControlLIN-ZHI INTERNATIONAL, INC.01082016-07-05
B07603570Methamphetamine DAU Control, Level 1 ControlLIN-ZHI INTERNATIONAL, INC.03572016-07-05
B07603580Methamphetamine DAU Control, Level 2 ControlLIN-ZHI INTERNATIONAL, INC.03582016-07-05
B076S0056B0Oral Fluid Methamphetamine Control, Level 1 ControlLIN-ZHI INTERNATIONAL, INC.S0056b2016-07-05
B076S0057B0Oral Fluid Methamphetamine Control, Level 2 ControlLIN-ZHI INTERNATIONAL, INC.S0057b2016-07-05
00884883011151CEDIA Methamphetamine OFT ControlsMicrogenics Corporation100149532017-10-30