Catalog Number

MDSC01

Brand Name

CoviSelf

Version/Model Number

MDSC01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 2100

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

819006f3-08df-44a1-a524-be9a612bf073

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 11, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-