Duns Number:561011079
Device Description: The ANDiS Viral RNA Auto Exttaction & Purification Kit is a system that uses automatic ma The ANDiS Viral RNA Auto Exttaction & Purification Kit is a system that uses automatic magnetic beads technology for isolation and purification of viral RNA from biological specimens. The product is intended to be used by professional users, such as technicians and physicians who are trained in molecular biological techniques. The ANDiS Viral RNA Auto Extraction & Purification Kit is intennded for in vitro diagnostic use.
Catalog Number
3103010046
Brand Name
ANDiS Viral RNA Auto Extraction & Purification Kit
Version/Model Number
64 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
56068e3d-e8ae-4d60-8226-e5138af433df
Public Version Date
January 20, 2021
Public Version Number
1
DI Record Publish Date
January 12, 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 |