Duns Number:429572365
Device Description: The CKMB UDR assay is an in vitro diagnostic test used for the kinetic quantitative determ The CKMB UDR assay is an in vitro diagnostic test used for the kinetic quantitative determination on Unicel DxC600, DxC800 and Synchron LX20 systems of the CK-MB isoenzyme activity of creatine kinase in serum and Li-heparin plasma by inhibition method.
Catalog Number
A53720
Brand Name
CKMB UDR
Version/Model Number
A53720
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K102706
Product Code
JHS
Product Code Name
Differential Rate Kinetic Method, Cpk Or Isoenzymes
Public Device Record Key
7d8737c3-c7f4-4d35-9ab7-066bd31728a0
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 | 11 |
2 | A medical device with a moderate to high risk that requires special controls. | 16 |