BioFire® Respiratory Panel 2.1-EZ EUA, 30 Tests

Basic Information

• Brand Name: BioFire® Respiratory Panel 2.1-EZ EUA, 30 Tests
• Primary DI: 00815381020239
• Version / Model: 423883
• Company Name: BIOFIRE DIAGNOSTICS, LLC
• Labeler DUNS: 079280262
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-25
• Public Version: 2
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: ce52f497-d051-40bf-a147-e024d13d6eda

Device Description

IVD reagent kit containing 30 tests.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
61527	Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms (bacteria, fungi and/or viruses) associated with respiratory disease in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, influenza A, respiratory syncytial viruses A and B, rhinovirus, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, and/or enterovirus.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815381020239	GS1