Duns Number:595361724
Device Description: The Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) is used for magnetic beads-based n The Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) is used for magnetic beads-based nucleic acid extraction from virus in biological specimens. The kit is intended for in vitro diagnostic use.
Catalog Number
300395
Brand Name
Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24)
Version/Model Number
300395
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
d5a0c636-1812-454a-a719-c164b653d216
Public Version Date
May 21, 2020
Public Version Number
1
DI Record Publish Date
May 13, 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 |