FDA.reportPublic FDA data

Audit MicroControls Linearity FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, U

Primary DI
B085K846M100
Brand
Audit MicroControls Linearity FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, U
Company
AALTO SCIENTIFIC
Model
K846M-10
Device description
"Note - Max characters were exceeded for Brand Name field. Brand name is ""Audit MicroControls Linearity FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UCH-L1)"". "
Published
2024-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B085K846M100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple traumatic brain injury marker IVD, controlA 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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
077974989
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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