Audit MicroControls Linearity FD Traumatic Brain Injury (TBI)

GUDID B085K739M100

AALTO SCIENTIFIC

Multiple traumatic brain injury marker IVD, control

• Primary Device ID: B085K739M100
• NIH Device Record Key: 1960155f-3f7e-4a33-97bd-838f5abe2741
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Audit MicroControls Linearity FD Traumatic Brain Injury (TBI)
• Version Model Number: K739M-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	B085K739M100 [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: 2025-04-18
• Device Publish Date: 2025-04-10

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