JBAIDS - JBAIDS IVD Influenza A & B Detection Kit - BIOFIRE DEFENSE, LLC

Duns Number:556915205

Device Description: JBAIDS IVD Influenza A & B Detection Kit

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More Product Details

Catalog Number

JRPD-ASY-0137

Brand Name

JBAIDS

Version/Model Number

JRPD-ASY-0137

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 14, 2017

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

OCC

Product Code Name

Respiratory Virus Panel Nucleic Acid Assay System

Device Record Status

Public Device Record Key

a061b810-0a48-4a68-8529-3df48a142989

Public Version Date

February 12, 2020

Public Version Number

4

DI Record Publish Date

September 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOFIRE DEFENSE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 14
U Unclassified 1