Duns Number:243942278
Device Description: Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and C Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, Plasma, or Serum.
Catalog Number
CS3002
Brand Name
Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test
Version/Model Number
CS3002
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K020950,K022409,K020950,K022409
Product Code
DEA
Product Code Name
Myoglobin, Fitc, Antigen, Antiserum, Control
Public Device Record Key
f67d07bc-dfd4-46cf-8165-19509b9e8123
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 15, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-