FilmArray® Respiratory Panel (RP) EZ RFIT-ASY-0120

GUDID 00815381020147

IVD reagent kit containing 30 tests.

BIOFIRE DIAGNOSTICS, LLC

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

• Primary Device ID: 00815381020147
• NIH Device Record Key: 61e67b33-a151-409a-a818-5d9b00fcfed9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FilmArray® Respiratory Panel (RP) EZ
• Version Model Number: RFIT-ASY-0120
• Catalog Number: RFIT-ASY-0120
• 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	00815381020147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152579

FDA Product Code

• OZX: Mycoplasma Pneumoniae Dna Assay System

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: 2016-12-06

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