FilmArray® Pneumonia Panel (Pneumo)

GUDID 00815381020178

IVD reagent kit containing 30 tests

BIOFIRE DIAGNOSTICS, LLC

Multiple respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00815381020178
• NIH Device Record Key: 6ce0d8b1-dd34-4253-a08d-b09dc33fa151
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FilmArray® Pneumonia Panel (Pneumo)
• Version Model Number: RFIT-ASY-0144
• 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: true
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815381020178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180966

FDA Product Code

• QBH: Lower Respiratory Microbial Nucleic Acid Detection System
• QDP: Respiratory Panel

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: 2019-01-14
• Device Publish Date: 2018-12-12

On-Brand Devices [FilmArray® Pneumonia Panel (Pneumo)]

• 00815381020185: IVD reagent kit containing 6 tests
• 00815381020178: IVD reagent kit containing 30 tests