Catalog Number

11206254

Brand Name

Atellica IM FT3

Version/Model Number

11206254

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K991692,K991692

Product Code

CDP

Product Code Name

RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Public Device Record Key

3339ef25-945c-4454-8d72-08eba8c3aeb2

Public Version Date

November 18, 2021

Public Version Number

3

DI Record Publish Date

May 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-