Catalog Number

10995679

Brand Name

Atellica IM T3

Version/Model Number

10995679

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

K041133

Product Code

CDP

Product Code Name

RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Public Device Record Key

ecd10537-3b26-4cb4-9e06-4e233b2c7a44

Public Version Date

November 18, 2021

Public Version Number

5

DI Record Publish Date

February 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-