Duns Number:126544316
Device Description: In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creati In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human serum and plasma
Catalog Number
CD301S
Brand Name
Nano-CheckTM AMI 3 in 1
Version/Model Number
CD301S
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
K050975,K050975
Product Code
DDR
Product Code Name
Myoglobin, Antigen, Antiserum, Control
Public Device Record Key
394b6b4e-f109-4b6d-ae00-a3c0ea0bea6d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 14, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-