Catalog Number

EA001012

Brand Name

ePlex System

Version/Model Number

ePlex Respiratory Panel (RP)

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

K163636

Product Code

OCC

Product Code Name

Respiratory Virus Panel Nucleic Acid Assay System

Public Device Record Key

54c96299-7b9d-4627-b15a-703efee6e057

Public Version Date

August 23, 2019

Public Version Number

3

DI Record Publish Date

December 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-