FDA.reportPublic FDA data

Multiple clinical chemistry enzyme IVD, reagent

Definition
A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple clinical chemistry enzymes. Analytes detected may include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP).
GUDID devices
6
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00630414008950ADVIA Chemistry P5PL_c ReagentSiemens Healthcare Diagnostics Inc.107297822021-11-04
00894472000237B CassetteOPTI MEDICAL SYSTEMS, INC.12019-08-07
00894472000244OPTI CCA E CassetteOPTI MEDICAL SYSTEMS, INC.12019-08-07
00894472000251E-Ca Cassette CartonOPTI MEDICAL SYSTEMS, INC.12019-09-03
00894472000268OPTI CCA E-Cl CassetteOPTI MEDICAL SYSTEMS, INC.12019-09-03
00894472000275OPTI CCA E-Glu CassetteOPTI MEDICAL SYSTEMS, INC.12019-09-03