AccessGUDID - DEVICE: JBAIDS (00851458005013)

GUDID

Device Identifier (DI) Information

Brand Name: JBAIDS
Version or Model: JRPD-ASY-0016
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: JRPD-ASY-0016
Company Name: BIOFIRE DEFENSE, LLC

Primary DI Number: 00851458005013
Issuing Agency: GS1
Commercial Distribution End Date: January 22, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 556915205 *Terms of Use

Device Description: JBAIDS IVD Q Fever Detection Kit

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):	Yes
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?
51346	Coxiella burnetii 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 Coxiella burnetii in a clinical specimen, using a nucleic acid technique (NAT). The assay is designed to detect infection with Coxiella burnetii, the rickettsial bacteria associated with Q fever.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OVF	Assay, Direct, Nucleic Acid Amplification, Q Fever

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: 3b5db035-5fb8-45b0-b11b-5c1fab646deb
Public Version Date: April 05, 2022
Public Version Number: 4
DI Record Publish Date: September 07, 2016