Duns Number:126544316
Device Description: Fluorescence in vitro diagnostic test kit for the detection of cardiac troponin I in human Fluorescence in vitro diagnostic test kit for the detection of cardiac troponin I in human while blood, serum and plasma of myocardial infarction patients
Catalog Number
TF3151
Brand Name
Fluoro-CheckTM cTnI
Version/Model Number
TF3151
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
-
Product Code Name
-
Public Device Record Key
6b7503ad-c20f-4517-86b9-1a04edb2ad4d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 14, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-