Duns Number:595361724
Device Description: The Sentosa SQ 318 Chip Kit is used to perform up to 200 base-read sequencing of enriched, The Sentosa SQ 318 Chip Kit is used to perform up to 200 base-read sequencing of enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonally amplified DNA.
Catalog Number
300300
Brand Name
Sentosa SQ 318 Chip Kit (8)
Version/Model Number
300300
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
e6177b87-6e2f-4ed6-84b7-070e3c835295
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 |