BIOFIRE ® SPOTFIRE ® Module

GUDID 00815381020369

IVD Instrument (SPOTFIRE ® Module).

BIOFIRE DIAGNOSTICS, LLC

Thermal cycler nucleic acid amplification analyser IVD, laboratory

• Primary Device ID: 00815381020369
• NIH Device Record Key: 552816f4-ba7c-4bcb-ae13-a83d2b7bab33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOFIRE ® SPOTFIRE ® Module
• Version Model Number: FAST-ASY-0002
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00815381020369 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213954

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

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: 2023-04-14
• Device Publish Date: 2023-04-06

On-Brand Devices [BIOFIRE ® SPOTFIRE ® Module]

• 00815381020376: Used IVD Instrument (SPOTFIRE® Module).
• 00815381020369: IVD Instrument (SPOTFIRE ® Module).