FDA.reportPublic FDA data

Multiple traumatic brain injury marker IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple biochemical markers associated with traumatic brain injury in a clinical specimen. The biochemical markers commonly include glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1).
GUDID devices
10
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B085K083M80Audit MicroControls Control FD Traumatic Brain Injury (TBI)AALTO SCIENTIFICK083M-82026-03-25
B085K739M100Audit MicroControls Linearity FD Traumatic Brain Injury (TBI)AALTO SCIENTIFICK739M-102025-04-10
B085K852M200Audit MicroControls Method Val FD UCH-L1 for bioMérieux VIDAS® TBI (UCH-L1)AALTO SCIENTIFICK852M-202025-01-06
B085K846M100Audit MicroControls Linearity FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UAALTO SCIENTIFICK846M-102024-12-06
B085K089M80Audit MicroControls Control FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UCHAALTO SCIENTIFICK089M-82024-12-06
B085K846M50Audit MicroControls Linearity FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UAALTO SCIENTIFICK846M-52024-12-06
B085K853M200Audit MicroControls Method Val FD GFAP for bioMérieux VIDAS® TBI (GFAP)AALTO SCIENTIFICK853M-202024-12-06
00054749004959i-STATABBOTT POINT OF CARE INC.06P17-242021-10-12
00054749004966i-STATABBOTT POINT OF CARE INC.06P17-252021-10-12
00054749004973i-STATABBOTT POINT OF CARE INC.06P17-262021-10-12