Duns Number:595361724
Device Description: The ViroKey™ SX Virus Total Nucleic Acid Kit is used for magnetic beads-based nucleic acid The ViroKey™ SX Virus Total Nucleic Acid Kit is used for magnetic beads-based nucleic acid extraction from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples in conjunction with the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 on the Sentosa® SX101 instrument.
Catalog Number
300677
Brand Name
ViroKey™ SX Virus Total Nucleic Acid Kit
Version/Model Number
300677
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
8753ff28-1c60-4697-b69e-ba2ecc7f8356
Public Version Date
July 07, 2020
Public Version Number
1
DI Record Publish Date
June 29, 2020
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |