FilmArray® Meningitis/Encephalitis (ME) Panel RFIT-ASY-0119

GUDID 00815381020130

IVD reagent kit containing 6 tests.

BIOFIRE DIAGNOSTICS, LLC

Multiple meningitis-associated microorganism nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00815381020130
• NIH Device Record Key: b8e67541-affd-4aa0-8841-4eb027a63894
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FilmArray® Meningitis/Encephalitis (ME) Panel
• Version Model Number: RFIT-ASY-0119
• Catalog Number: RFIT-ASY-0119
• 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	00815381020130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN150013

FDA Product Code

• PLO: Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection 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: 4
• Public Version Date: 2018-08-08
• Device Publish Date: 2016-09-23

On-Brand Devices [FilmArray® Meningitis/Encephalitis (ME) Panel]

• 00815381020130: IVD reagent kit containing 6 tests.
• 00815381020123: IVD reagent kit containing 30 tests.