FilmArray® 2.0 Instrument FLM2-ASY-0001

GUDID 00815381020031

IVD Instrument (FilmArray® 2.0 Instrument).

BIOFIRE DIAGNOSTICS, LLC

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

• Primary Device ID: 00815381020031
• NIH Device Record Key: a54c194b-030d-4fdb-916b-80eb2a310346
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FilmArray® 2.0 Instrument
• Version Model Number: FLM2-ASY-0001
• Catalog Number: FLM2-ASY-0001
• Company DUNS: 079280262
• Company Name: BIOFIRE DIAGNOSTICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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
GS1	00815381020031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143178

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [FilmArray® 2.0 Instrument]

• 00815381020048: Refurbished IVD Instrument (FilmArray® 2.0 Instrument).
• 00815381020031: IVD Instrument (FilmArray® 2.0 Instrument).
• 00815381029058: Refurbished IVD Instrument (FilmArray® 2.0 Instrument).