Duns Number:561011079
Device Description: The 96A Automated Viral RNA Isolation Kit utilizes magnetic beads-based technology for aut The 96A Automated Viral RNA Isolation Kit utilizes magnetic beads-based technology for automated isolation and purification of RNA from biological samples. The product is intended to be used by professional users that are trained in molecular biological techniques.
Catalog Number
3000000000012
Brand Name
96A Automated Viral RNA Isolation Kit
Version/Model Number
96 Tests
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
JJH
Product Code Name
Clinical Sample Concentrator
Public Device Record Key
91910c92-7fd7-4c11-8f05-ff926d17f0ee
Public Version Date
October 05, 2021
Public Version Number
1
DI Record Publish Date
September 27, 2021
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 | 14 |