Duns Number:276816717
Device Description: VIDAS ® NT- proBNP is a quantitative test for use on the VIDAS instruments for the determi VIDAS ® NT- proBNP is a quantitative test for use on the VIDAS instruments for the determination of N terminal fragment of B- type natriuretic peptide in serum/plasma.
Catalog Number
-
Brand Name
VIDAS® NT-proBNP
Version/Model Number
30449-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 08, 2016
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NBC
Product Code Name
Test,Natriuretic Peptide
Public Device Record Key
3262782f-2361-424c-8412-8ca939dbfa7b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |