Catalog Number

-

Brand Name

Accutest iFOBT - Single Sample Immunological Fecal Occult Blood Test

Version/Model Number

CS625

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

K063693,K063693

Product Code

KHE

Product Code Name

Reagent, Occult Blood

Public Device Record Key

8e606626-b7c5-42ae-95b8-87a34c7a5d4b

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-