Audit MicroControls Linearity FLQ Special Diabetes for Roche Systems

GUDID B085K922M50

AALTO SCIENTIFIC

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: B085K922M50
• NIH Device Record Key: 59a2863e-5ab6-444f-ac13-ec38d8cf6e68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Audit MicroControls Linearity FLQ Special Diabetes for Roche Systems
• Version Model Number: K922M-5
• 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	B085K922M50 [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: 2025-09-22
• Device Publish Date: 2024-12-16

On-Brand Devices [Audit MicroControls Linearity FLQ Special Diabetes for Roche Systems]

• B085K929M50: K929M-5
• B085K922M50: K922M-5