AccessGUDID - DEVICE: JBAIDS (00851458005006)

GUDID

Device Identifier (DI) Information

Brand Name: JBAIDS
Version or Model: JB01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: JRPD-ASY-0001
Company Name: BIOFIRE DEFENSE, LLC

Primary DI Number: 00851458005006
Issuing Agency: GS1
Commercial Distribution End Date: September 08, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 556915205 *Terms of Use

Device Description: JBAIDS Instrument

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
48033	Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated	An electrically-powered laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen prior to amplification, and generally operates with reduced technician involvement and automation of some, but not all procedural steps.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NHT	Assay, Nucleic Acid Amplification, Bacillus Anthracis

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: 29ffced7-fc8b-4da4-b666-9deec3855b0a
Public Version Date: April 20, 2022
Public Version Number: 5
DI Record Publish Date: September 07, 2016