FDA.reportPublic FDA data

Total protein 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 protein in a clinical specimen.
GUDID devices
78
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00896863002349QuanTtest Red Pyrogallol Red ReagentQUANTIMETRIX CORPORATION5210-122019-09-27
05204309127894Total ProteinMEDICON HELLAS S.A.1418-01862026-04-27
05204309161201Total ProteinMEDICON HELLAS S.A.1419-01852026-04-27
05204309162147Total ProteinMEDICON HELLAS S.A.1419-01862026-04-27
05051700020558Optilite® Low Level Total Protein ReagentTHE BINDING SITE GROUP LIMITEDNK061.L.OPT.A2024-10-30
00850053916144IDG/SanzayIDG/SANZAY Corporation12024-01-12
10673486002171Teco Diagnostics CSF/Urine Protein Reagent SetTECO DIAGNOSTICSP615-4802023-11-14
10673486002201Teco Diagnostics Total Protein Reagent SetTECO DIAGNOSTICST528-4802023-11-14
10673486002218Teco Diagnostics Total Protein Reagent Kit for TC-MatrixTECO DIAGNOSTICST528-1300TM2023-11-14
06971674868040BIOBASEBiobase Biodustry(Shandong)Co., Ltd.Calibrator:1mL×12023-07-24
06971674868392BIOBASEBiobase Biodustry(Shandong)Co., Ltd.Control:1mL×12023-07-24
06971674869252BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:70mL×22023-07-24
06971674869269BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:60mL×22023-07-24
06971674869276BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:50mL×22023-07-24
06971674869283BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:20mL×82023-07-24
06971674869290BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:20mL×22023-07-24
06971674862215BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:70mL×22023-07-21
06971674862222BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:60mL×22023-07-21
06971674862239BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:20mL×82023-07-21
06971674862246BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:20mL×22023-07-21
06971674862253BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:120mL×12023-07-21
06971674862260BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:40mL×42023-07-21
06971674862277BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:40mL×42023-07-21
06971674862284BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:80mL×22023-07-21
06971674862291BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:40mL×42023-07-21
06971674862307BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:100mL×22023-07-21
06971674862314BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:50mL×42023-07-21
06971674862321BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:40mL×42023-07-21
06971674862338BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:40mL×42023-07-21
06971674862352BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:20mL×82023-07-21
06971674862369BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:40mL×42023-07-21
06971674862376BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:40mL×42023-07-21
06971674862383BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:40mL×42023-07-21
10758750000593VITROSORTHO-CLINICAL DIAGNOSTICS, INC.68001202016-08-10
10758750004539VITROSORTHO-CLINICAL DIAGNOSTICS, INC.82084312016-08-26
10758750004850VITROSORTHO-CLINICAL DIAGNOSTICS, INC.83922922016-08-26
00380740155469ARCHITECTABBOTT IRELAND04U44202022-07-12
00380740155476ARCHITECTABBOTT IRELAND04U44302022-07-12
00380740155261AlinityABBOTT IRELAND04T81202022-06-30
00380740155278AlinityABBOTT IRELAND04T81302022-06-30
00811727015976Pointe Total Protein ReagentHORIBA INSTRUMENTS INCORPORATED14-T7528-4802021-01-30
00811727016270Pointe Total Protein ReagentHORIBA INSTRUMENTS INCORPORATED16-HT928-7082021-01-30
00380740161750ARCHITECTAbbott GmbH7D73-222019-10-24
M0515210120QuanTtest Red Pyrogallol Red ReagentQUANTIMETRIX CORPORATION5210-122017-06-30
05060500091286Synermed®INFRARED LABORATORY SYSTEMS LLCVI135-R2016-09-20
05060500091293Synermed®INFRARED LABORATORY SYSTEMS LLCVI135-X2016-09-20
05060500091309Synermed®INFRARED LABORATORY SYSTEMS LLCVI135-L2016-09-20
05060500091316Synermed®INFRARED LABORATORY SYSTEMS LLCVI530-R2016-09-20
05060500091323Synermed®INFRARED LABORATORY SYSTEMS LLCVI530-X2016-09-20
05060500091330Synermed®INFRARED LABORATORY SYSTEMS LLCVI530-WK2016-09-20
05060500091347Synermed®INFRARED LABORATORY SYSTEMS LLCVI530-9112016-09-20
05060500091354Synermed®INFRARED LABORATORY SYSTEMS LLCVI131-L2016-09-20
05060500091361Synermed®INFRARED LABORATORY SYSTEMS LLCVI133-L2016-09-20
05060500091941Synermed®INFRARED LABORATORY SYSTEMS LLCVI530-12002017-02-28
00845275002997Thermo Scientific Fisher DiagnosticsTR340262016-09-16
00852169008249ClearChem Diagnostics Inc. Protein, TotalCLEARCHEM DIAGNOSTICS INC.TPR13102018-04-30
00852223007164T. PROTEIN RGT SETSTERLING DIAGNOSTICS INC2240-02016-09-14
00857969006235ACEALFA WASSERMANN, INC.SA10222016-09-24
00817274021996JAS DiagnosticsDREW SCIENTIFIC, INC.TPT2-125U2016-09-12
00817274022009JAS DiagnosticsDREW SCIENTIFIC, INC.TPT2-1252016-09-12
00817274022016JAS DiagnosticsDREW SCIENTIFIC, INC.XL-TPT2-402016-09-12
00817274022023JAS DiagnosticsDREW SCIENTIFIC, INC.TPT2-BUL2016-09-12
00817274022474JAS DiagnosticsDREW SCIENTIFIC, INC.TPT2-1L2017-04-04
00817439021281MedTest DX Total Protein for the BS480Medtest Dx, Inc.TP4802016-09-27
00817439021304MedTest DX Total Protein for the BS200Medtest Dx, Inc.TP6002016-09-27
00811727011985Pointe Scientific, Inc. Total ProteinHORIBA INSTRUMENTS INCORPORATEDT7528-1202016-08-31
00811727011992Pointe Scientific, Inc. Total ProteinHORIBA INSTRUMENTS INCORPORATEDT7528-5002016-08-31
00811727012005Pointe Scientific, Inc. Total ProteinHORIBA INSTRUMENTS INCORPORATEDT7528-1L2016-08-31
00811727012777Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDHT928-12002016-08-31
00811727013101Pointe Scientific, Inc. Total ProteinHORIBA INSTRUMENTS INCORPORATEDHT928-5762016-08-31
00811727013651Total ProteinHORIBA INSTRUMENTS INCORPORATED12-T7528-1202016-08-31
00811727014382Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATED13-T7528-1202016-08-31
00811727014399Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATED13-T7528-5002016-08-31
00811727014832Pointe Scientific, Inc. Total ProteinHORIBA INSTRUMENTS INCORPORATEDHT928-30002016-08-31
00811727015112Pointe Scientific, Inc. Total ProteinHORIBA INSTRUMENTS INCORPORATEDOT928-5762016-08-31
00812137012036Total Protein ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.500mL2016-10-12
00380740012977ARCHITECTABBOTT LABORATORIES7D73-212016-09-09
00380740135249AlinityAbbott GmbH07P52202018-05-30