Catalog Number

900-0828

Brand Name

GeneXpert®

Version/Model Number

GXIV-HUB

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180218

Product Code

OOI

Product Code Name

Real Time Nucleic Acid Amplification System

Public Device Record Key

aecd4246-6efd-472e-9045-67130d5b6f18

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

May 12, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-