Catalog Number

RF520

Brand Name

Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge

Version/Model Number

10444895

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

K970343,K970343

Product Code

JHY

Product Code Name

COLORIMETRIC METHOD, CPK OR ISOENZYMES

Public Device Record Key

c9fa7e5c-2b4f-4105-b2ec-a3044d95299e

Public Version Date

November 18, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-