Duns Number:595361724
Device Description: Sentosa SA201 HSV-1/2 PCR Test is a real-time PCR based in vitro diagnostic test to detect Sentosa SA201 HSV-1/2 PCR Test is a real-time PCR based in vitro diagnostic test to detect and differentiate HSV1 and HSV2 virus DNA qualitatively.
Catalog Number
300216
Brand Name
Sentosa SA201 HSV-1/2 PCR Test
Version/Model Number
300216
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
OQO
Product Code Name
Herpes Simplex Virus Nucleic Acid Amplification Assay
Public Device Record Key
2d5c105b-d780-4747-8ef9-d6b83c532636
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
April 16, 2018
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 |