AccessGUDID - DEVICE: NGDS (00851458005099)

GUDID

Device Identifier (DI) Information

Brand Name: NGDS
Version or Model: NGDS-ASY-0006
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NGDS-ASY-0006
Company Name: BIOFIRE DEFENSE, LLC

Primary DI Number: 00851458005099
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 556915205 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NSU	Instrumentation For Clinical Multiplex Test Systems
OOI	Real Time Nucleic Acid Amplification System
PRD	Biothreat Microbial Agents Multiplex Nucleic Acid Detection System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8563833f-b6ca-462b-b964-293ef0e2aa07
Public Version Date: August 03, 2023
Public Version Number: 6
DI Record Publish Date: April 21, 2017