Duns Number:595361724
Device Description: Sentosa ST401i is used for emulsion PCR and forms part of SQ301 Platform.
Catalog Number
400124
Brand Name
Sentosa ST401i
Version/Model Number
400124
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PFF
Product Code Name
High Throughput Dna Sequence Analyzer
Public Device Record Key
2bcfb494-dfbb-4ad6-b85b-8073062457f4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 28, 2017
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 |