Catalog Number

12148340122

Brand Name

sTfR Control Set

Version/Model Number

12148340122

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K003064

Product Code

DDG

Product Code Name

TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

161ad021-6b75-4af3-a7e6-37f086bab3f4

Public Version Date

August 13, 2021

Public Version Number

3

DI Record Publish Date

February 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-