Duns Number:126544316
Device Description: In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglobin in huma In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglobin in human serum and plasma
Catalog Number
CD201S
Brand Name
Nano-CheckTM AMI 2 in 1
Version/Model Number
CD201S
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
K102441,K102441
Product Code
DDR
Product Code Name
Myoglobin, Antigen, Antiserum, Control
Public Device Record Key
2781b76f-d21a-4f4b-a3af-d2a65accd4b6
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
-