Catalog Number

LSC-210-20-00

Brand Name

LifeSign® MI Myo/TnI card

Version/Model Number

LSC-210-20-00

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K022946

Product Code

DEA

Product Code Name

Myoglobin, Fitc, Antigen, Antiserum, Control

Public Device Record Key

04203474-0be8-4ea8-a55b-9d953f0ba4af

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-