Duns Number:595361724
Device Description: The Sentosa SX IA Template Prep Kit is intended for isothermal template preparation after The Sentosa SX IA Template Prep Kit is intended for isothermal template preparation after library preparation is complete. it is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonally amplified DNA for up to 200 base-read sequencing of a library. The Sentosa SX IA Template Prep Kit is comprised of three components; the Sentosa SX IA Reactions Kit, the Sentosa SX IA Reagents Kit and the Sentosa SX IA Solutions Kit.
Catalog Number
300734
Brand Name
Sentosa SX IA Reagents Kit (8)
Version/Model Number
300734
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
3b2c387f-2960-4405-b4e2-ec0629d740ca
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 |