Duns Number:829978451
Device Description: MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control mat MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
Catalog Number
150
Brand Name
Cardiac Marker Control
Version/Model Number
150
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
K972976
Product Code
JJT
Product Code Name
Enzyme Controls (Assayed And Unassayed)
Public Device Record Key
6956f743-e3b8-4128-a39f-e4a79e360bc3
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 30, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 28 |