FDA.reportPublic FDA data

Amphetamine/methamphetamine group IVD, calibrator

Definition
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 the amphetamine and/or methamphetamine group(s) in a clinical specimen.
GUDID devices
25
Last updated
2020-10-05 06:30:15

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00811727016553Pointe Amphetamines 500 Calibrator (MAMP 250 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-AM0204-52020-09-25
00811727016560Pointe Amphetamines 500 Calibrator (MAMP 500 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-AM0206-52020-09-25
00811727016577Pointe Amphetamines 500 Calibrator (MAMP 1000 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-AM0208-52020-09-25
00811727016584Pointe Amphetamines 500 Calibrator (MAMP 2000 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-AM0210-52020-09-25
00811727016638Pointe Amphetamines 1000 Calibrator (MAMP 500 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-AM0084-52020-09-25
00811727016645Pointe Amphetamines 1000 Calibrator (MAMP 1000 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-AM0086-52020-09-25
00811727016652Pointe Amphetamines 1000 Calibrator (MAMP 1500 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-AM0088-52020-09-25
00811727016669Pointe Amphetamines 1000 Calibrator (MAMP 2000 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-AM0090-52020-09-25
10694644100355Rapid TOXAMERICAN BIO MEDICA CORPORATION10-METT-000 2016-09-23
10694644800019Rapid ONEAMERICAN BIO MEDICA CORPORATION10-METS-000 2016-09-23
B07601620Ecstasy DAU Calibrator, Low CalibratorLIN-ZHI INTERNATIONAL, INC.01622016-07-05
B07601630Ecstasy DAU Calibrator, Cutoff CalibratorLIN-ZHI INTERNATIONAL, INC.01632016-07-05
B07601640Ecstasy DAU Calibrator, Intermediate CalibratorLIN-ZHI INTERNATIONAL, INC.01642016-07-05
B07601650Ecstasy DAU Calibrator, High CalibratorLIN-ZHI INTERNATIONAL, INC.01652016-07-05
05055273207859MDMA CALRANDOX LABORATORIES LIMITEDDA27012016-09-24
00842768001796Syva® Emit® Calibrator B Level 1 (cutoff)Siemens Healthcare Diagnostics Inc.104454122016-09-24
00842768001802Syva® Emit® Calibrator B Level 2 (high)Siemens Healthcare Diagnostics Inc.104454132016-09-24
00842768016486Dimension Vista® EXTC CALSiemens Healthcare Diagnostics Inc.104451882016-09-24
00858724003551ARK™ Methylphenidate Metabolite CalibratorARK DIAGNOSTICS INC5042-0002-002018-09-29
00858724003575ARK™ Methylphenidate Negative CalibratorARK DIAGNOSTICS INC5042-0002-012018-09-29
00858724003582ARK™ Methylphenidate Metabolite Cutoff Calibrator ARK DIAGNOSTICS INC5042-0002-022018-09-29
00884883001374DRI Ecstasy 1000 ng/mL CalibratorMicrogenics Corporation1000792016-09-12
00884883001381DRI Ecstasy 750 ng/mL CalibratorMicrogenics Corporation1000802016-09-12
00884883001398DRI Ecstasy 500 ng/mL CalibratorMicrogenics Corporation1000812016-09-12
00884883001404DRI Ecstasy 250 ng/mL CalibratorMicrogenics Corporation1000822016-09-12