Catalog Number

900-0456

Brand Name

GeneXpert Infinity-80 System

Version/Model Number

INFINITY 48-40

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

-

Product Code

OOI

Product Code Name

Real Time Nucleic Acid Amplification System

Public Device Record Key

e1461840-5340-44d0-82cf-922e7a3dcdc5

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

May 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-