Duns Number:126544316
Device Description: Analyzer for Nano-CheckTM line of diagnostic products.
Catalog Number
NDT710
Brand Name
Nano-CheckerTM 710 Reader
Version/Model Number
710V
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
-
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
18cf24b3-f794-4e33-8844-0810085d1857
Public Version Date
March 08, 2022
Public Version Number
3
DI Record Publish Date
March 29, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-