Catalog Number

900-0521R

Brand Name

Certified Pre-Owned GeneXpert Dx System

Version/Model Number

GXXVI-16-R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 03, 2022

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

K060540,K173263

Product Code

OOI

Product Code Name

Real Time Nucleic Acid Amplification System

Public Device Record Key

2c35f2cc-1e8c-477f-bbdc-8c2810df59b4

Public Version Date

September 16, 2022

Public Version Number

7

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-