FDA.reportPublic FDA data

Iron 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 iron in a clinical specimen.
GUDID devices
18
Last updated
2023-11-21 07:36:15

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10673486001983Teco Diagnostics Iron/TIBC Reagent SetTECO DIAGNOSTICSI592-1002023-11-13
10673486002003Teco Diagnostics Iron Reagent Kit for TC MatrixTECO DIAGNOSTICSI592-380TM2023-11-13
10758750000289VITROSORTHO-CLINICAL DIAGNOSTICS, INC.19245472020-04-18
10758750009244VITROSORTHO-CLINICAL DIAGNOSTICS, INC.15158082020-04-18
SO910852042008Rowley Biochemical Muller's Colloidal Iron Oxide Stock SolutionTRANSENE COMPANY, INC.12019-09-16
05060500090982Synermed®INFRARED LABORATORY SYSTEMS LLCIR320-R2016-09-20
05060500090999Synermed®INFRARED LABORATORY SYSTEMS LLCIR320-X2016-09-20
05060500091002Synermed®INFRARED LABORATORY SYSTEMS LLCIR320-WK2016-09-20
05060500091019Synermed®INFRARED LABORATORY SYSTEMS LLCIR320-9112016-09-20
05060500091026Synermed®INFRARED LABORATORY SYSTEMS LLCIR321-L2016-09-20
05060500091033Synermed®INFRARED LABORATORY SYSTEMS LLCIR322-L2016-09-20
05060500091903Synermed®INFRARED LABORATORY SYSTEMS LLCIR320-12002017-02-28
00852169008188ClearChem Diagnostics Inc. IronCLEARCHEM DIAGNOSTICS INC.IRN11502018-04-30
00852223007072SERUM IRON/IBCSTERLING DIAGNOSTICS INC2200-02016-09-14
00857969006495ACEALFA WASSERMANN, INC.SA10172017-10-10
00811727012708Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDHI904-6002016-08-31
00811727013040Pointe Scientific Inc. IronHORIBA INSTRUMENTS INCORPORATEDHI904-4982016-08-31
00812137011992Iron Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.R1 x 500mL, R2 x 15mL2016-10-12