Catalog Number

-

Brand Name

EZ Detect Colon Disease Test

Version/Model Number

1000-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2020

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

K860028

Product Code

KHE

Product Code Name

Reagent, Occult Blood

Public Device Record Key

b24c2937-47fb-4044-8d20-99f35387aa9f

Public Version Date

September 02, 2021

Public Version Number

4

DI Record Publish Date

December 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-