FilmArray® Pneumonia Panel (Pneumo)

GUDID 00815381020185

IVD reagent kit containing 6 tests

BIOFIRE DIAGNOSTICS, LLC

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

• Primary Device ID: 00815381020185
• NIH Device Record Key: d618448c-a291-4a00-9b72-12b385e05667
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FilmArray® Pneumonia Panel (Pneumo)
• Version Model Number: RFIT-ASY-0145
• 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	00815381020185 [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