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

GUDID B085K089M80

Note - Max characters were exceeded for Brand Name field. Brand name is "Audit MicroControls Control FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UCH-L1)".

AALTO SCIENTIFIC

Multiple traumatic brain injury marker IVD, control

• Primary Device ID: B085K089M80
• NIH Device Record Key: bb27d505-09d8-4002-9822-d282e500b918
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Audit MicroControls Control FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UCH
• Version Model Number: K089M-8
• 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	B085K089M80 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-16
• Device Publish Date: 2024-12-06

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