Audit MicroControls Method Val FD GFAP for bioMérieux VIDAS® TBI (GFAP)

GUDID B085K853M200

AALTO SCIENTIFIC

Multiple traumatic brain injury marker IVD, control

• Primary Device ID: B085K853M200
• NIH Device Record Key: dc76cc59-a799-4dcb-ba2b-5cb89fe8eded
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Audit MicroControls Method Val FD GFAP for bioMérieux VIDAS® TBI (GFAP)
• Version Model Number: K853M-20
• 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	B085K853M200 [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

Devices Manufactured by AALTO SCIENTIFIC

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• B085K866M50 - Audit MicroControls Linearity FD General Chemistry Panel 3 for Alfa Wassermann: 2025-03-14
• B085K867M100 - Audit MicroControls Linearity FD General Chemistry Panel 4 for Alfa Wassermann: 2025-03-14
• B085K061M60 - Audit MicroControls Control FD HbA1c: 2025-02-03
• B085K852M200 - Audit MicroControls Method Val FD UCH-L1 for bioMérieux VIDAS® TBI (UCH-L1): 2025-01-14