FDA.reportPublic FDA data

Cannabinoid 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 cannabinoids in a clinical specimen.
GUDID devices
62
Last updated
2020-10-05 06:30:14

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00811727017260Pointe Cannabinoids (THC) Negative Calibrator (0 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-TH0004-52020-09-25
00811727017277Pointe Cannabinoids (THC) Calibrator (12.5 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-TH0144-52020-09-25
00811727017284Pointe Cannabinoids (THC) Calibrator (25 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-TH0146-52020-09-25
00811727017291Pointe Cannabinoids (THC) Calibrator/Control (37.5 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-TH0014-52020-09-25
00811727017307Pointe Cannabinoids (THC) Calibrator (50 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-TH0150-52020-09-25
00811727017338Pointe Cannabinoids (THC) Calibrator Control (75 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-TH0152-52020-09-25
00811727017345Pointe Cannabinoids (THC) Calibrator (100 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-TH0154-52020-09-25
00811727017369Pointe Cannabinoids (THC) Calibrator (150 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-TH0156-52020-09-25
00811727017376Pointe Cannabinoids (THC) Calibrator (200 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-TH0158-52020-09-25
10758750002832VITROSORTHO-CLINICAL DIAGNOSTICS, INC.68025622016-08-23
00840937107973ImmunalysisIMMUNALYSIS CORP10011-152016-08-31
00840937107980Immunalysis CorporationIMMUNALYSIS CORP10011-252016-08-31
00840937107997ImmunalysisIMMUNALYSIS CORP10012-152016-08-31
00840937108000Immunalysis CorporationIMMUNALYSIS CORP10012-252016-08-31
00840937108017ImmunalysisIMMUNALYSIS CORP10013-152016-08-31
00840937108024Immunalysis CorporationIMMUNALYSIS CORP10013-252016-08-31
00840937108031ImmunalysisIMMUNALYSIS CORP10014-152016-08-31
00840937108048Immunalysis CorporationIMMUNALYSIS CORP10014-252016-08-31
00840937108345ImmunalysisIMMUNALYSIS CORP10011-52016-09-13
00840937108352ImmunalysisIMMUNALYSIS CORP10012-52016-09-13
00840937108369ImmunalysisIMMUNALYSIS CORP10013-52016-09-13
00840937108376ImmunalysisIMMUNALYSIS CORP10014-52016-09-13
00380740168223AlinityABBOTT LABORATORIES09P54012020-01-06
00380740168230AlinityABBOTT LABORATORIES09P54022020-01-06
00380740168247AlinityABBOTT LABORATORIES09P54032020-01-06
15099590224868SynchronBeckman Coulter, Inc.4458142016-08-24
15099590229559SynchronBeckman Coulter, Inc.4458112016-08-24
15099590230500SynchronBeckman Coulter, Inc.4458092016-08-24
15099590231644SynchronBeckman Coulter, Inc.4643902016-08-24
B0760002C0Cannabinoids DAU Calibrator, Negative CalibratorLIN-ZHI INTERNATIONAL, INC.0002c2016-07-05
B0760072C0Cannabinoids DAU Calibrator, CalibratorLIN-ZHI INTERNATIONAL, INC.0072c2016-07-05
B0760073C0Cannabinoids DAU Calibrator, CalibratorLIN-ZHI INTERNATIONAL, INC.0073c2016-07-05
B0760075C0Cannabinoids DAU Calibrator, CalibratorLIN-ZHI INTERNATIONAL, INC.0075c2016-07-05
B0760077C0Cannabinoids DAU Calibrator, CalibratorLIN-ZHI INTERNATIONAL, INC.0077c2016-07-05
B0760078C0Cannabinoids DAU Calibrator, CalibratorLIN-ZHI INTERNATIONAL, INC.0078c2016-07-05
B0760079C0Cannabinoids DAU Calibrator, CalibratorLIN-ZHI INTERNATIONAL, INC.0079c2016-07-05
B076S0072C0Oral Fluid Cannabinoid Calibrator, Negative CalibratorLIN-ZHI INTERNATIONAL, INC.S0072c2016-07-05
B076S0073C0Oral Fluid Cannabinoid Calibrator, Low CalibratorLIN-ZHI INTERNATIONAL, INC.S0073c2016-07-05
B076S0074C0Oral Fluid Cannabinoid Calibrator, Cutoff CalibratorLIN-ZHI INTERNATIONAL, INC.S0074c2016-07-05
B076S0075C0Oral Fluid Cannabinoid Calibrator, Intermediate CalibratorLIN-ZHI INTERNATIONAL, INC.S0075c2016-07-05
B076S0076C0Oral Fluid Cannabinoid Calibrator, High CalibratorLIN-ZHI INTERNATIONAL, INC.S0076c2016-07-05
05055273207842THC CALRANDOX LABORATORIES LIMITEDDA27002016-09-24
00842768002151Syva® Emit® 5B3 THC Calibrator 50Siemens Healthcare Diagnostics Inc.104454662016-09-24
00884883001909CEDIA THC 25 CalibratorMicrogenics Corporation15575052016-09-24
00884883001916CEDIA THC 50 CalibratorMicrogenics Corporation15575132016-09-24
00884883001923CEDIA THC 75 CalibratorMicrogenics Corporation15575212016-09-24
00884883001930CEDIA THC 100 Calibrator Microgenics Corporation15575302016-09-24
00884883001947CEDIA THC 150 Calibrator Microgenics Corporation15575482016-09-12
00884883004924DRI THC 20 ng/mL Urine Calibrator Microgenics Corporation13972016-09-24
00884883004955DRI THC 200 ng/mL Urine Calibrator Microgenics Corporation14002016-09-24
00884883004962DRI THC 50 ng/mL Urine Calibrator Microgenics Corporation13982016-09-24
00884883004979DRI THC 100 ng/mL Urine Calibrator Microgenics Corporation13992016-09-24
00884883005723CEDIA THC OFT Cutoff CalibratorMicrogenics Corporation100149232016-09-12
00884883005730CEDIA THC OFT Negative CalibratorMicrogenics Corporation100149222016-09-12
00884883011465DRI THC 200 ng/mL Urine Calibrator Microgenics Corporation02062016-09-24
00884883011472DRI THC 50 ng/mL Urine Calibrator Microgenics Corporation00422016-09-24
00884883011519DRI THC 100 ng/mL Urine Calibrator Microgenics Corporation00442016-09-24
00884883011526DRI THC 20 ng/mL Urine Calibrator Microgenics Corporation02352016-09-24
00380740005603ARCHITECTABBOTT LABORATORIES3L41-012016-06-06
00380740005610ARCHITECTABBOTT LABORATORIES3L41-022016-06-06
00380740005627ARCHITECTABBOTT LABORATORIES3L41-032016-06-06
00380740005634ARCHITECTABBOTT LABORATORIES3L41-042016-06-06