BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel

GUDID 00815381020390

IVD reagent kit containing 30 tests.

BIOFIRE DIAGNOSTICS, LLC

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

• Primary Device ID: 00815381020390
• NIH Device Record Key: 1727c63c-a059-4740-a8dc-2cd054b130bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel
• Version Model Number: 423485
• 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: 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	00815381020390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232954

FDA Product Code

• OZZ: Bordetella Pertussis Dna Assay 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: 2024-05-13
• Device Publish Date: 2024-05-03

Devices Manufactured by BIOFIRE DIAGNOSTICS, LLC

• 00815381020727 - BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini: 2024-08-05 IVD reagent kit containing 30 tests.
• 00815381020390 - BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel: 2024-05-13IVD reagent kit containing 30 tests.
• 00815381020390 - BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel: 2024-05-13 IVD reagent kit containing 30 tests.
• 00815381020765 - BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini: 2023-05-17 IVD reagent kit containing 30 tests.
• 00815381020055 - BIOFIRE ® SPOTFIRE ® Control Station: 2023-04-14 IVD Instrument (SPOTFIRE ® Control Station).
• 00815381020352 - BIOFIRE ® SPOTFIRE ® Control Station: 2023-04-14 Used IVD Instrument (SPOTFIRE® Control Station).
• 00815381020369 - BIOFIRE ® SPOTFIRE ® Module: 2023-04-14 IVD Instrument (SPOTFIRE ® Module).
• 00815381020376 - BIOFIRE ® SPOTFIRE ® Module: 2023-04-14 Used IVD Instrument (SPOTFIRE® Module).
• 00815381020659 - BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel: 2023-04-14 IVD reagent kit containing 30 tests.