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

GUDID B085K846M100

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)".

AALTO SCIENTIFIC

Multiple traumatic brain injury marker IVD, control

• Primary Device ID: B085K846M100
• NIH Device Record Key: f11e1092-b6fb-425a-9b07-7a280c039ed6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Audit MicroControls Linearity FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, U
• Version Model Number: K846M-10
• Company DUNS: 077974989
• Company Name: AALTO SCIENTIFIC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B085K846M100 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-01-09
• Device Publish Date: 2024-12-06

On-Brand Devices [Audit MicroControls Linearity FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, U]

• B085K846M50: Note - Max characters were exceeded for Brand Name field. Brand name is "Audit MicroControls Li
• B085K846M100: Note - Max characters were exceeded for Brand Name field. Brand name is "Audit MicroControls Li