Catalog Number

-

Brand Name

NA

Version/Model Number

R30850601

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 11, 2021

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K780874

Product Code

DDC

Product Code Name

Thyroglobulin, Antigen, Antiserum, Control

Public Device Record Key

d52fc79d-5259-42a2-abc4-d8d38e5d20b4

Public Version Date

May 13, 2022

Public Version Number

4

DI Record Publish Date

December 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-