Catalog Number

GXNOV-10

Brand Name

Xpert Norovirus

Version/Model Number

GXNOV-10

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

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

K142501

Product Code

PCH

Product Code Name

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Public Device Record Key

57c9e56e-aedf-469a-9f1a-b59256bfd3b6

Public Version Date

December 21, 2020

Public Version Number

4

DI Record Publish Date

January 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-