Duns Number:126544316
Device Description: In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human serum and pl In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human serum and plasma
Catalog Number
CD7141
Brand Name
Nano-CheckTM AMI cTnI
Version/Model Number
CD7141
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
K102131,K102131
Product Code
MMI
Product Code Name
Immunoassay Method, Troponin Subunit
Public Device Record Key
1a9f3bc0-9ed4-4a0e-931d-7e2253521b57
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 14, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-