Catalog Number

11420592

Brand Name

Atellica IM Calcitonin

Version/Model Number

11420592

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

K182012

Product Code

JKR

Product Code Name

RADIOIMMUNOASSAY, CALCITONIN

Public Device Record Key

021a2f8a-5c69-4a26-882c-ba1e2db8a7ba

Public Version Date

November 18, 2021

Public Version Number

3

DI Record Publish Date

July 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-