FDA.reportPublic FDA data

Creatine kinase (CK) multiple isoenzyme 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 qualitative and/or quantitative detection of one or multiple creatine kinase (CK) isoenzymes in a clinical specimen.
GUDID devices
24
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
M5255516740Blade Applicator Kit, 20 SampleHELENA LABORATORIES CORPORATION5516742016-09-07
M5255517650Blade Applicator Kit, 20 SampleHELENA LABORATORIES CORPORATION5517652016-09-07
M5255520150SPIFE CK-20,40 Gel KitHELENA LABORATORIES CORPORATION5520152016-09-07
M5255520280SPIFE CK Reagent KitHELENA LABORATORIES CORPORATION5520282016-09-07
M5255523960QuickGel CK Vis Gel KitHELENA LABORATORIES CORPORATION5523962016-09-07
M5255525890Blade Applicator Kit, 20 SampleHELENA LABORATORIES CORPORATION5525892016-09-07
M5255525900Blade Applicator Kit, 20 SampleHELENA LABORATORIES CORPORATION5525902016-09-07
M525552612SPIFE CK-20,40 Gel KitHELENA LABORATORIES CORPORATION5526122017-02-10
05055273201390CK NACRANDOX LABORATORIES LIMITEDCK1102016-09-16
05055273201406CK NACRANDOX LABORATORIES LIMITEDCK1132016-09-09
05055273201468CKRANDOX LABORATORIES LIMITEDCK28132016-09-16
05055273201475CK NACRANDOX LABORATORIES LIMITEDCK3352016-09-16
05055273201482CK NACRANDOX LABORATORIES LIMITEDCK38122016-09-16
05055273201505CK NACRANDOX LABORATORIES LIMITEDCK38782016-09-16
05055273201543CK NACRANDOX LABORATORIES LIMITEDCK5222016-09-16
05055273201581CK-NACRANDOX LABORATORIES LIMITEDCK79472016-09-16
00851445007136GENCHEM™ CK-NAC ReagentGENCHEM INCGEN-CK R12016-09-19
00851445007143GENCHEM™ CK-NAC ReagentGENCHEM INCGEN-CK R22016-09-19
00817302020489CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CK RGT KIT Product No. ST207CAROLINA LIQUID CHEMISTRIES CORPORATIONST2072016-09-01
00817302020496CAROLINA LIQUID CHEMISTRIES CORP.® CK RGT. KIT BL-207CAROLINA LIQUID CHEMISTRIES CORPORATIONBL2072016-09-01
00817302020502CAROLINA LIQUID CHEMISTRIES CORP.® CK RGT. KIT AU-207CAROLINA LIQUID CHEMISTRIES CORPORATIONAU-2072016-09-01
00817302020519CAROLINA LIQUID CHEMISTRIES CORP.™ CK CREATINE KINASE REAGENT CC207CAROLINA LIQUID CHEMISTRIES CORPORATIONCC2072016-09-01
00817302023039CAROLINA LIQUID CHEMISTRIES CORP.® CK REAGENT PRODUCT NO. DT207CAROLINA LIQUID CHEMISTRIES CORPORATIONDT2072016-10-17
00812137011954CK-NAC Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.R1 x 120mL, R2 x 30mL2016-10-12