Duns Number:126544316
Device Description: In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin, Creatine In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin, Creatine kinase MB and Nt-proBNP in human serum and plasma
Catalog Number
CD402P
Brand Name
Nano-CheckTM 4 in 1 Test
Version/Model Number
CD402P
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
DDR
Product Code Name
Myoglobin, Antigen, Antiserum, Control
Public Device Record Key
1637c2e0-aa95-4a23-bd21-f0c3f0997488
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
October 03, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-