Duns Number:126544316
Device Description: An in vitro diagnostic test for the detection of Dengue NS1 protein in human whole blood o An in vitro diagnostic test for the detection of Dengue NS1 protein in human whole blood of dengue infected patient from acute to convalescent stage.
Catalog Number
MD8143
Brand Name
Nano-CheckTM Dengue NS1
Version/Model Number
MD8143
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
OSU
Product Code Name
Dengue Serological Reagents
Public Device Record Key
5f849588-fdfb-478b-97b9-93c43b719c35
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 08, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-