NGDS

Basic Information

• Brand Name: NGDS
• Primary DI: 00851458005099
• Version / Model: NGDS-ASY-0006
• Catalog Number: NGDS-ASY-0006
• Company Name: BIOFIRE DEFENSE, LLC
• Labeler DUNS: 556915205
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-21
• Public Version: 6
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: 8563833f-b6ca-462b-b964-293ef0e2aa07
• Distribution End Date: 2018-02-01

Device Description

FilmArray® NGDS Warrior Panel - IVD reagent Biothreat Detection Kit containing 30 tests.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• 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
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	862.2570	2
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	862.2570	2
PRD	Biothreat Microbial Agents Multiplex Nucleic Acid Detection System

GMDN Terms

Code	Name	Definition	Implantable	Status
62711	Multiple-type biothreat/febrile infection-associated 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 (e.g., bacteria and viruses such as Bacillus anthracis, Francisella tularensis, Yersinia pestis, Ebola virus, influenza A virus) associated with biothreat/febrile infection in a clinical specimen, using a nucleic acid technique (NAT). It is typically used to aid diagnosis incidences of suspected exposure to biological agents used in bioterrorism or biological warfare.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851458005099	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]