Catalog Number

07027583190

Brand Name

Elecsys Myoglobin

Version/Model Number

07027583190

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

K083260

Product Code

DDR

Product Code Name

MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

2a897a10-3abb-4465-a579-510efe414da1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-