Duns Number:561011079
Device Description: The ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling kit is a system that The ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling kit is a system that uses automatic magnetic beads technology for isolation and purification of viral RNA from biological specimens (nasopharyngeal, oropharyngeal swabs or anterior nasal swab). The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as technicians and physicians who are trained in molecular biological techniques.
Catalog Number
3103010040
Brand Name
ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling Kit
Version/Model Number
64Tests
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
96492ef8-9206-4dc3-9094-e9831165c44d
Public Version Date
December 08, 2021
Public Version Number
1
DI Record Publish Date
November 30, 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 |