Identity
- Trade Name
- PGDx elio™ platform FDA UDI
- Generic Name
- Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- B0110900 FDA UDI
Identifiers
- Catalog Number
- B0110900 FDA UDI
- Primary DI / UDI-DI
- 00192721000763 FDA UDI
- 510(k) Number
- K192063 FDA UDI
- FDA Product Code
- PZM FDA UDI
- GMDN Term
- Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
PGDx elio™ platform by Personal Genome Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT).
- Prosigna Breast Cancer Prognostic Gene Signature Assay — Nanostring Technologies · Class II
- Prosigna Breast Cancer Prognostic Gene Signature Assay — Nanostring Technologies · Class II
- TruSight™ Oncology Comprehensive — Illumina, Inc. · Class III
- Prosigna Breast Cancer Prognostic Gene Signature Assay — Nanostring Technologies · Class II
- Prosigna Breast Cancer Prognostic Gene Signature Assay — Nanostring Technologies · Class II
- Prosigna Breast Cancer Prognostic Gene Signature Assay — Nanostring Technologies · Class II
- MI Cancer Seek® — CARIS MPI, INC. · Class III
- PGDx elio™ server — Personal Genome Diagnostics, Inc. · Class II
Cleared under the same submission
K192063 also covers:
- PGDx elio™ server — Personal Genome Diagnostics, Inc.
- PGDx elio™ server — Personal Genome Diagnostics, Inc.
- PGDx elio™ server — Personal Genome Diagnostics, Inc.
- PGDx elio™ server — Personal Genome Diagnostics, Inc.
- PGDx elio™ tissue complete — Personal Genome Diagnostics, Inc.
- PGDx elio™ tissue complete — Personal Genome Diagnostics, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Personal Genome Diagnostics, Inc.
Sources (1)
- FDA UDI be2d8122-a070-4ea6-a60a-00ec72cfb394 34 fields · synced May 31, 2026