Duns Number:243942278
Device Description: Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparini Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum.
Catalog Number
CS1002
Brand Name
Cardiac STATus® TnI
Version/Model Number
CS1002
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
K014105,K014105
Product Code
MMI
Product Code Name
Immunoassay Method, Troponin Subunit
Public Device Record Key
72a48fa2-52b8-4a74-97c1-a00f9db474a2
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
-