Duns Number:126544316
Device Description: Fluorescence In Vitro Diagnostic Test kit for the determination of NT-proBNP (N-terminal p Fluorescence In Vitro Diagnostic Test kit for the determination of NT-proBNP (N-terminal pro-Brain natriuretic peptide) in human whole blood, serum or plasma
Catalog Number
TF3152
Brand Name
Fluoro-CheckTM NT-proBNP
Version/Model Number
TF3152
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
293b7375-c433-472e-be54-b08a737a6a5f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 05, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-