Duns Number:045623154
Device Description: CK Reagent is for the quantitative determination of creatine kinase activity in serum on H CK Reagent is for the quantitative determination of creatine kinase activity in serum on Hitachi analyzers.
Catalog Number
HC922-300
Brand Name
Pointe Scientific, Inc. CK
Version/Model Number
HC922-300
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
K972155
Product Code
CGS
Product Code Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Public Device Record Key
f8309429-d3c6-4fb4-b4d6-b8ee62cac89c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |