FDA.reportPublic FDA data

Ethanol (ETOH) IVD, calibrator

Definition
A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen.
GUDID devices
14
Last updated
2023-06-21 07:33:20

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10758750005048VITROSORTHO-CLINICAL DIAGNOSTICS, INC.85781632016-08-23
15099590222079SynchronBeckman Coulter, Inc.4749942016-08-24
05060500091606Synermed®INFRARED LABORATORY SYSTEMS LLCIR952-ETOH2016-09-20
00842768001970Syva® Emit® Ethyl Alcohol Negative CalibratorSiemens Healthcare Diagnostics Inc.104454452016-09-24
00842768001994Syva® Emit® Ethyl Alcohol 100 mg/dL CalibratorSiemens Healthcare Diagnostics Inc.104454482016-09-24
00852553007247Ethanol Standard KitVERICHEM LABORATORIES, INC.96702018-01-16
00852553007346Ethanol Standard, Level DVERICHEM LABORATORIES, INC.96742018-01-16
00884883005129DRI Negative Alcohol CalibratorMicrogenics Corporation14052016-09-12
00884883005198DRI 100 mg/dL Alcohol Calibrator Microgenics Corporation14062016-09-12
00884883011540DRI 100 mg/dL Alcohol Calibrator Microgenics Corporation02412016-09-12
00884883011564DRI Negative Alcohol CalibratorMicrogenics Corporation03112016-09-12
00811727010087POINTE SCIENTIFIC Alcohol StandardHORIBA INSTRUMENTS INCORPORATEDA7504-STD2016-08-31
00380740005511ARCHITECTABBOTT LABORATORIES3L36-012016-06-06
00380740005528ARCHITECTABBOTT LABORATORIES3L36-022016-06-06