Catalog Number

GXEV-100N-10

Brand Name

Xpert EV

Version/Model Number

GXEV-100N-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

DEN070004

Product Code

OAI

Product Code Name

Assay, Enterovirus Nucleic Acid

Public Device Record Key

79a234fa-e00b-408f-9378-2c85b16c4652

Public Version Date

December 21, 2020

Public Version Number

5

DI Record Publish Date

January 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-