FDA.reportPublic FDA data

Total creatine kinase (CK) 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 creatine kinase (CK) in a clinical specimen.
GUDID devices
26
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850053916090IDG/SanzayIDG/SANZAY Corporation12024-01-09
00850053916106IDG/SanzayIDG/SANZAY Corporation12024-01-09
10673486001495Teco Diagnostics Creatine Kinase (CK-NAC) Reagent SetTECO DIAGNOSTICSC512-602023-07-27
10673486001501Teco Diagnostics Creatine Kinase (CK-NAC) Reagent SetTECO DIAGNOSTICSC512-2402023-07-27
10673486001594Teco Diagnostics Creatine Kinase (CK-NAC) Liquid ReagentTECO DIAGNOSTICSC519-1502023-07-27
10673486001617Teco Diagnostics Creatine Kinase (CK-NAC) Liquid Reagent TC MatrixTECO DIAGNOSTICSC519-440TM2023-07-27
10758750004973VITROSORTHO-CLINICAL DIAGNOSTICS, INC.84780342016-08-23
10758750004980VITROSORTHO-CLINICAL DIAGNOSTICS, INC.84793962016-08-23
00380740132590AlinityAbbott GmbH08P42202019-05-07
00380740161699ARCHITECTAbbott GmbH7D63-222020-01-25
00380740161705ARCHITECTAbbott GmbH7D63-422020-01-25
05060500090661Synermed®INFRARED LABORATORY SYSTEMS LLCUV310-R2016-09-20
05060500090678Synermed®INFRARED LABORATORY SYSTEMS LLCUV310-X2016-09-20
05060500090685Synermed®INFRARED LABORATORY SYSTEMS LLCUV310-WK2016-09-20
05060500090692Synermed®INFRARED LABORATORY SYSTEMS LLCUV311A-L2016-09-20
05060500090708Synermed®INFRARED LABORATORY SYSTEMS LLCUV311B-L2016-09-20
05060500090715Synermed®INFRARED LABORATORY SYSTEMS LLCUV312A-L2016-09-20
05060500090722Synermed®INFRARED LABORATORY SYSTEMS LLCUV312B-L2016-09-20
05060500091866Synermed®INFRARED LABORATORY SYSTEMS LLCUV310-12002017-02-28
00845275002300Thermo Scientific Fisher DiagnosticsTR140102016-09-16
00845275002348Thermo Scientific Fisher DiagnosticsTR143142017-06-22
00852169008089ClearChem Diagnostics Inc. Creatine Kinase (CK)CLEARCHEM DIAGNOSTICS INC.CPK11102018-04-30
00852223007034CPK / COLORIMETRICSTERLING DIAGNOSTICS INC2155-02016-09-14
00857969006075ACEALFA WASSERMANN, INC.RX20112016-09-24
00857969006143ACEALFA WASSERMANN, INC.SA20112016-09-24
00380740012878ARCHITECTABBOTT LABORATORIES7D63-212016-06-06