FDA.report

Multiple electrolyte IVD, control

Definition
A material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.
GUDID devices
9
Last updated
2023-08-17 07:27:52

Related Product Codes

CodeDeviceSpecialtyClassDevices
GLKControl, HematocritHematology24
JJSControls For Blood-Gases, (Assayed And Unassayed)Clinical Chemistry14
JGSElectrode, Ion Specific, SodiumClinical Chemistry21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00852676007155Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.1001P2023-08-09
00852676007162Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.1002P2023-08-09
00852676007179Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.1003P2023-08-09
00852676007186Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.1004P2023-08-09
08426951293827ChemSTAT Hematocrit Evaluator 1INSTRUMENTATION LABORATORY COMPANY000440001042019-06-26
08426951293834ChemSTAT Hematocrit Evaluator 2INSTRUMENTATION LABORATORY COMPANY000440001052019-06-26
08426951293841ChemSTAT Hematocrit Evaluator 3INSTRUMENTATION LABORATORY COMPANY000440001062019-06-26
08426951293858GEM ChemSTAT critPVP 1-4INSTRUMENTATION LABORATORY COMPANY000440015162019-06-26
15099590140014AUBeckman Coulter, Inc.AUH10172016-09-24