FDA.reportPublic FDA data

Total bilirubin IVD, reagent

Definition
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total bilirubin in a clinical specimen.
GUDID devices
32
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00852169008317ClearChem Diagnostics Inc. Total BilirubinCLEARCHEM DIAGNOSTICS INC.BRB2122023-01-20
05204309089130Total BilirubinMEDICON HELLAS S.A.1418-01492026-04-27
05204309161362Total BilirubinMEDICON HELLAS S.A.1419-01422026-04-27
10673486001280Teco Diagnostics Total Bilirubin TC MatrixTECO DIAGNOSTICSB576-380TM2023-07-21
10673486001297Teco Diagnostics Total Bilirubin Reagent SetTECO DIAGNOSTICSB576-4802023-07-21
10673486001303Teco Diagnostics Direct and Total Bilirubin Reagent SetTECO DIAGNOSTICSB577-4802023-07-21
10758750004461VITROSORTHO-CLINICAL DIAGNOSTICS, INC.81599312016-08-10
10758750004829VITROSORTHO-CLINICAL DIAGNOSTICS, INC.83830512016-08-23
10758750009398VITROSORTHO-CLINICAL DIAGNOSTICS, INC.16123652016-08-23
00192024029317Ricca Chemical Company®Ricca Chemical Company, LLC2780-42021-02-04
00192024029324Ricca Chemical Company®Ricca Chemical Company, LLC2780-162021-02-04
05055273200782T BILRANDOX LABORATORIES LIMITEDBR23612016-09-16
05055273200829T BILRANDOX LABORATORIES LIMITEDBR28022016-09-16
05055273200843T BILRANDOX LABORATORIES LIMITEDBR38592016-09-16
05055273200867BILRANDOX LABORATORIES LIMITEDBR4122016-09-16
05055273208306T BILRANDOX LABORATORIES LIMITEDBR83072016-09-16
05055273208337T BILRANDOX LABORATORIES LIMITEDBR97662016-09-16
05060500090340Synermed®INFRARED LABORATORY SYSTEMS LLCIR700-R2016-09-20
05060500090357Synermed®INFRARED LABORATORY SYSTEMS LLCIR700-X2016-09-20
05060500090364Synermed®INFRARED LABORATORY SYSTEMS LLCIR700-WK2016-09-20
05060500090371Synermed®INFRARED LABORATORY SYSTEMS LLCIR700-9112016-09-20
05060500090388Synermed®INFRARED LABORATORY SYSTEMS LLCIR700-L2016-09-20
05060500090395Synermed®INFRARED LABORATORY SYSTEMS LLCIR450-R2016-09-20
05060500090401Synermed®INFRARED LABORATORY SYSTEMS LLCIR450-X2016-09-20
05060500090418Synermed®INFRARED LABORATORY SYSTEMS LLCIR451-L2016-09-20
05060500090425Synermed®INFRARED LABORATORY SYSTEMS LLCIR452-L2016-09-20
05060500091828Synermed®INFRARED LABORATORY SYSTEMS LLCIR700-12002017-02-28
00852169008102ClearChem Diagnostics Inc. Bilirubin, TotalCLEARCHEM DIAGNOSTICS INC.BRB10602018-04-30
00852223007218TOTAL AND DIRECT BILIRUBINSTERLING DIAGNOSTICS INC2130-02016-09-14
00852223007232TOTAL BILIRUBINSTERLING DIAGNOSTICS INC2135-02016-09-14
00857969006099ACEALFA WASSERMANN, INC.SA10082016-09-24
00695684132002AIMTAB BILIRUBIN TABLETSGERMAINE LABORATORIES, INC132002016-04-27