FDA.reportPublic FDA data

Albumin 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 albumin in a clinical specimen.
GUDID devices
38
Last updated
2023-12-26 07:56:12

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850053916007IDG/SanzayIDG/SANZAY Corporation12023-12-18
10673486001013Albumin Reagent SetTECO DIAGNOSTICSA502-4802023-07-07
10673486001020Albumin -BCG method TC-MatrixTECO DIAGNOSTICSA502-510TM2023-07-07
10758750000388VITROSORTHO-CLINICAL DIAGNOSTICS, INC.19882112016-08-23
10758750004522VITROSORTHO-CLINICAL DIAGNOSTICS, INC.81960572016-08-23
00811403011605Albumin ReagentDiamond Diagnostics Inc.BK-467858D2023-06-10
00192024031143Ricca Chemical Company®Ricca Chemical Company, LLC2950-322021-02-04
00192024031150Ricca Chemical Company®Ricca Chemical Company, LLC2950-162021-02-04
00192024068545Ricca Chemical Company®Ricca Chemical Company, LLC6630-322021-02-04
00192024068552Ricca Chemical Company®Ricca Chemical Company, LLC6630-162021-02-04
00812137011848Albumin ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.500 mL2016-10-12
08058056681973Albumin BCP (6x20 mL)SENTINEL CH. SPAC228552020-02-24
08058056681980Albumin BCP (6x50 mL)SENTINEL CH. SPAC228562020-02-24
00380740161644ARCHITECTAbbott GmbH7D53-242019-11-15
05055273200034ALBRANDOX LABORATORIES LIMITEDAB38002016-09-16
05055273200041ALBRANDOX LABORATORIES LIMITEDAB3622016-09-16
05055273200058ALBRANDOX LABORATORIES LIMITEDAB38002016-09-16
05055273208115ALBRANDOX LABORATORIES LIMITEDAB83012016-09-16
05060500090029Synermed®INFRARED LABORATORY SYSTEMS LLCIR010-R2016-09-20
05060500090036Synermed®INFRARED LABORATORY SYSTEMS LLCIR010-X2016-09-20
05060500090043Synermed®INFRARED LABORATORY SYSTEMS LLCIR010-WK2016-09-20
05060500090050Synermed®INFRARED LABORATORY SYSTEMS LLCIR010-9112016-09-20
05060500090067Synermed®INFRARED LABORATORY SYSTEMS LLCIR010-L2016-09-20
05060500091682Synermed®INFRARED LABORATORY SYSTEMS LLCIR010-12002017-02-28
00851445007006GENCHEM™ Albumin ReagentGENCHEM INCGEN-ALB2016-09-19
00851445007013GENCHEM™ Albumin ReagentGENCHEM INCGEN-ALB-G2016-09-19
00852169008010ClearChem Diagnostics Inc. AlbuminCLEARCHEM DIAGNOSTICS INC.ALB10002018-04-30
00852223007171ALBUMIN RGT SETSTERLING DIAGNOSTICS INC2110-02016-09-14
00857969006136ACEALFA WASSERMANN, INC.SA20012016-09-24
00081213701184Albumin ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.500 mL2016-10-12
00817302020212CAROLINA LIQUID CHEMISTRIES CORP.® ALB (BCG) CC224CAROLINA LIQUID CHEMISTRIES CORPORATIONCC2242016-09-01
00817302020229CAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214CAROLINA LIQUID CHEMISTRIES CORPORATIONCC2142016-09-01
00817302020946CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214CAROLINA LIQUID CHEMISTRIES CORPORATIONAU-2142016-09-01
00817302022957CAROLINA LIQUID CHEMISTRIES CORP.® ALB REAGENT PRODUCT NO. DT224CAROLINA LIQUID CHEMISTRIES CORPORATIONDT2242016-10-17
00380740012816ARCHITECTABBOTT LABORATORIES7D54-212016-06-06
00380740082079ARCHITECTABBOTT LABORATORIES7D53-232016-09-09
00380740121716AlinityAbbott GmbH08P02202018-07-11
00380740121723AlinityAbbott GmbH08P03202018-07-11