FDA UDI
In Commercial Distribution
🇺🇸 United States
PiVAT Software
DI: 00860001218275
·
Model: SFW-2012 2.0
·
Pillar Biosciences, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PiVAT Software
- Primary DI
- 00860001218275
- Version / Model
- SFW-2012 2.0
- Catalog Number
- SFW-2012
- Company Name
- Pillar Biosciences, Inc.
- Labeler DUNS
- 117965650
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-20
- Public Version
- 3
- Public Version Date
- 2024-04-22
- Public Version Status
- Update
- Public Device Record Key
- f6b3899f-3417-45db-9d7f-82b2dae55f1d
Device Description
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 applicable reports for the oncoReveal CDx
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PQP | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62532 | Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to determine multiple genotypes associated with colorectal cancer, which may include BRAF, KRAS, APC, NRAS, PIK3CA, and/or CTNNB1 gene mutations, using a nucleic acid technique (NAT). It may be used to select treatment options and/or monitor the response to cancer therapy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860001218275 | GS1 |