Catalog Number

-

Brand Name

OraQuick Ebola Rapid Antigen Test

Version/Model Number

3001-2940

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

DEN190025,DEN190025

Product Code

QID

Product Code Name

Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

Public Device Record Key

f6ffa959-f1ef-4d29-a0d4-1279ab368812

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 01, 2020

Package DI Number

00608337001433

Quantity per Package

25

Contains DI Package

00608337001426

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box