Duns Number:595361724
Device Description: The Sentosa ST Template Kit is used to prepare enriched, template-positive Ion Sphere™ Par The Sentosa ST Template Kit is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonal amplified DNA for up to 200 base-read sequencing of a library.Sentosa ST Template Kit is comprised of four components; Sentosa ST Template Supplies, Sentosa ST Template Solutions, Sentosa ST Template Reagents and Sentosa ST Template Beads.
Catalog Number
300319
Brand Name
Sentosa ST Template Reagents (8)
Version/Model Number
300319
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
PFT
Product Code Name
Reagents For Molecular Diagnostic Test Systems
Public Device Record Key
50f64752-363d-400f-8e4b-267659a3ba5e
Public Version Date
January 27, 2021
Public Version Number
1
DI Record Publish Date
January 19, 2021
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 |