Duns Number:561011079
Device Description: The Viral RNA Auto Extraction & Purification Kit utilize magnetic beads-based technology f The Viral RNA Auto Extraction & Purification Kit utilize 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
3103010059
Brand Name
96A Viral RNA Auto Extraction & Purification Kit
Version/Model Number
96 Tests/Kit
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
b670ec78-9aab-4208-b17e-2fccdfdb45d5
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
January 13, 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 |