Duns Number:117965650
Device Description: The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a pre The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to analyze sequencer data to generate applciable reports for the oncoReveal Lung and Colon Cancer Assay.
Catalog Number
SFW-2002
Brand Name
PiVAT Software
Version/Model Number
SFW-2002 1.2
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PQP
Product Code Name
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Public Device Record Key
f6b3899f-3417-45db-9d7f-82b2dae55f1d
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
September 20, 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 |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 6 |