FDA.report

Cannabinoid 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 cannabinoids in a clinical specimen.
GUDID devices
40
Last updated
2020-10-05 06:30:14

Related Product Codes

CodeDeviceSpecialtyClassDevices
LASDrug Specific Control MaterialsClinical Toxicology127
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry115
DLJCalibrators, Drug SpecificClinical Toxicology25
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry13

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00811727017314Pointe Cannabinoids (THC) Control (18.75 ng/mL)POINTE SCIENTIFIC, INC.60-TH0012-52020-09-25
00811727017321Pointe Cannabinoids (THC) Control (31.25 ng/mL)POINTE SCIENTIFIC, INC.60-TH0148-52020-09-25
00811727017352Pointe Cannabinoids (THC) Control (62.5 ng/mL)POINTE SCIENTIFIC, INC.60-TH0016-52020-09-25
00811727017383Pointe Cannabinoids (THC) Control (125 ng/mL)POINTE SCIENTIFIC, INC.60-TH0018-52020-09-25
B800918045THC COOH HYDROLYSIS QCUTAK LABORATORIES, INC.918042020-07-24
00840937108055Immunalysis CorporationIMMUNALYSIS CORPORATION3005-152016-08-31
00840937108062Immunalysis CorporationIMMUNALYSIS CORPORATION3005-252016-08-31
00840937108383Immunalysis CorporationIMMUNALYSIS CORPORATION3005-52016-09-13
00380740165208AlinityABBOTT LABORATORIES09P54102020-01-06
00380740179380AlinityABBOTT LABORATORIES09P54112020-01-06
15099590223427SynchronBeckman Coulter, Inc.4721102016-08-24
15099590223434SynchronBeckman Coulter, Inc.4721072016-08-24
15099590227234SynchronBeckman Coulter, Inc.4659142016-08-24
15099590227258SynchronBeckman Coulter, Inc.4659122016-08-24
15099590228743SynchronBeckman Coulter, Inc.4659392016-08-24
B0760006C0Cannabinoids DAU Control, ControlLIN-ZHI INTERNATIONAL, INC.0006c2016-07-05
B0760007C0Cannabinoids DAU Calibrator/Control, Calibrator/CoLIN-ZHI INTERNATIONAL, INC.0007c2016-07-05
B0760008C0Cannabinoids DAU Control, ControlLIN-ZHI INTERNATIONAL, INC.0008c2016-07-05
B0760009C0Cannabinoids DAU Control, ControlLIN-ZHI INTERNATIONAL, INC.0009c2016-07-05
B0760074C0Cannabinoids DAU Control, ControlLIN-ZHI INTERNATIONAL, INC.0074c2016-07-05
B0760076C0Cannabinoids DAU Calibrator/Control, Calibrator/CoLIN-ZHI INTERNATIONAL, INC.0076c2016-07-05
B076S0077C0Oral Fluid Cannabinoid Control, Level 1 ControlLIN-ZHI INTERNATIONAL, INC.S0077c2016-07-05
B076S0078C0Oral Fluid Cannabinoid Control, Level 2 ControlLIN-ZHI INTERNATIONAL, INC.S0078c2016-07-05
05055273207958THC CONTROL 1RANDOX LABORATORIES LIMITEDDA31272016-09-24
05055273207965THC CONTROL 2RANDOX LABORATORIES LIMITEDDA31282016-09-24
00884883001954CEDIA DAU THC 50 Control SetMicrogenics Corporation16610782017-09-28
00884883004863CEDIA DAU THC 25 Control SetMicrogenics Corporation16610862017-09-28
00884883004870CEDIA DAU THC 100 Control SetMicrogenics Corporation16610602017-09-28
00884883004993DRI THC 40 ng/mL Urine ControlMicrogenics Corporation14012017-10-19
00884883005006DRI THC 60 ng/mL Urine ControlMicrogenics Corporation14022017-10-19
00884883005013DRI THC 75 ng/mL Urine ControlMicrogenics Corporation02142017-10-19
00884883005020DRI THC 125 ng/mL Urine ControlMicrogenics Corporation14042017-10-19
00884883005709CEDIA THC OFT Controls KitMicrogenics Corporation100149252017-10-30
00884883011441DRI THC 40 ng/mL Urine ControlMicrogenics Corporation01702017-10-19
00884883011496DRI THC 60 ng/mL Urine ControlMicrogenics Corporation01682017-10-19
00884883011533DRI THC 125 ng/mL Urine ControlMicrogenics Corporation02122017-10-19
00380740005641ARCHITECTABBOTT LABORATORIES3L41-102016-06-06
00380740005658ARCHITECTABBOTT LABORATORIES3L41-122016-06-06
00380740005665ARCHITECTABBOTT LABORATORIES3L41-142016-06-06
00380740005672ARCHITECTABBOTT LABORATORIES3L41-162016-06-06