Catalog Number

660476

Brand Name

Flowflex COVID-19 Antigen Home Test

Version/Model Number

L031-125P5

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

QKP

Product Code Name

Coronavirus antigen detection test system.

Public Device Record Key

974164ff-8b60-4509-97ca-667db70cbfe2

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

November 22, 2021

Package DI Number

20682607660470

Quantity per Package

600

Contains DI Package

00682607660476

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton