BioFire® Joint Infection (JI) Panel

GUDID 00815381020192

IVD reagent kit containing 30 kits.

BIOFIRE DIAGNOSTICS, LLC

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

• Primary Device ID: 00815381020192
• NIH Device Record Key: 0e1befe7-d3f2-4cd5-8036-655f0474a6f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioFire® Joint Infection (JI) Panel
• Version Model Number: RFIT-ASY-0138
• 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	00815381020192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200066

FDA Product Code

• QSN: Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

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: 2022-07-08
• Device Publish Date: 2022-06-30

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