Catalog Number

TF8145

Brand Name

Fluoro-CheckTM iFOB

Version/Model Number

TF8145

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

OOX

Product Code Name

Automated Occult Blood Analyzer

Public Device Record Key

2a21c793-fcad-470f-82b0-8930c2702a19

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

May 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-