FDA.reportPublic FDA data

Beta-hydroxybutyrate IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of beta-hydroxybutyrate (3-hydroxybutyric acid) in a clinical specimen.
GUDID devices
14
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00613647025277FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FH2460-6052023-06-20
00613647025284FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FH2465-6052023-06-20
00817089023154DiazymeDIAZYME LABORATORIES, INC.DZ153A-CON2023-11-29
20613647025271FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FH2460-6052023-06-20
20613647025288FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FH2465-6052023-06-20
10885380173158CARDINAL HEALTHCardinal Health 200, LLCCH24506042019-12-11
10885380173165CARDINAL HEALTHCardinal Health 200, LLCCH24606052019-12-11
10885380173172CARDINAL HEALTHCardinal Health 200, LLCCH24656052019-12-11
B085K728M50Audit MicroControls Linearity LQ Beta-Hydroxybutyric AcidAALTO SCIENTIFICK728M-52018-03-27
04051839002914β-Hydroxybutyrate 21 Tri-Level ControlsDiaSys Diagnostic Systems GmbH5957099430852018-10-29
04051839002921β-Hydroxybutyrate 21 Bi-Level ControlsDiaSys Diagnostic Systems GmbH5954099430842018-11-15
00657498000106STAT-Site B-HB ControlsSTANBIO LABORATORY, L.P.3030002016-09-24
00657498000533TDM/B-Hydroxybutyrate Tri-Level ControlsSTANBIO LABORATORY, L.P.2460-6052016-09-23
00657498000540TDM/B-Hydroxybutyrate Bi-Level ControlsSTANBIO LABORATORY, L.P.2465-6052016-09-23