Duns Number:561011079
Device Description: 96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of vi 96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DNA and RNA from biological specimens (Nasopharyngeal Swabs, Oropharyngeal Swabs, Saliva and Cervical Swabs) by using automatic magnetic beads technology. The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as laboratory personnel who has been trained.
Catalog Number
3000000000493
Brand Name
96A Automated Viral DNA/RNA Isolation Kit
Version/Model Number
500 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
-
Prescription Use (Rx)
Yes
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
14900b2b-fed0-4f52-91ae-a6f68c30fa62
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
October 02, 2022
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 |