Duns Number:227530649
Device Description: The device is intended for use in the calibration of CK-MB assays in clinical chemistry sy The device is intended for use in the calibration of CK-MB assays in clinical chemistry systems.
Catalog Number
CK2393
Brand Name
CK-MB CAL
Version/Model Number
CK2393
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
K123977
Product Code
JIT
Product Code Name
Calibrator, Secondary
Public Device Record Key
76b4cd3a-c7bc-43c2-a624-f8638bf22a8f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |