Duns Number:126544316
Device Description: In Vitro Diagnostic Test kit for the detection of Creatine kinase MB in human whole blood, In Vitro Diagnostic Test kit for the detection of Creatine kinase MB in human whole blood, serum and plasma
Catalog Number
CD7142
Brand Name
Nano-CheckTM AMI CK-MB
Version/Model Number
CD7142
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JHT
Product Code Name
Chromatographic Separation, Cpk Isoenzymes
Public Device Record Key
a22418ca-a538-4a98-a5ef-ca3570b6e14c
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
October 05, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-