Catalog Number

-

Brand Name

iHealth

Version/Model Number

ICO-3000

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)

-

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

acdfe43f-c25d-4848-9500-354a234eb85c

Public Version Date

September 26, 2022

Public Version Number

1

DI Record Publish Date

September 16, 2022

Package DI Number

10856362005897

Quantity per Package

1

Contains DI Package

00856362005890

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-