Catalog Number

GBBORD-10

Brand Name

Bordetella Direct Test

Version/Model Number

GBBORD-10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

OOI

Product Code Name

Real Time Nucleic Acid Amplification System

Public Device Record Key

dfc7d2ba-b3cb-4b0f-a537-f07ce9ef030a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 12, 2017

Package DI Number

B178GBBORD102

Quantity per Package

10

Contains DI Package

B178GBBORD100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box