Duns Number:170119536
Device Description: DS2 Automated ELISA Processing System
Catalog Number
62000
Brand Name
DYNEX DS2
Version/Model Number
62000
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
JJQ
Product Code Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Public Device Record Key
ee5e2a2d-af5f-425a-92f5-72b1118f6def
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
February 07, 2022
Package DI Number
15060456180314
Quantity per Package
1
Contains DI Package
05060456180317
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |