FDA Registration
Active
🇺🇸 United States
PERSONAL GENOME DIAGNOSTICS INC.
Reg #: 3011805506
·
FEI: 3011805506
·
Expires 2026
Products
5
Proprietary Names
3
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- PERSONAL GENOME DIAGNOSTICS INC.
- Registration Number
- 3011805506
- FEI Number
- 3011805506
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3600 Boston Street
- City
- Baltimore
- State
- MD
- ZIP
- 21224
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192063
Owner / Operator
- Firm Name
- Personal Genome Diagnostics
- Operator Number
- 10059661
- Address
- 3600 Boston Street
- City
- Baltimore
- State
- MD
- Postal Code
- 21224
- Country
- US
- Correspondent
- Jennifer Dickey
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tumor Gene Profiling Test | QFK | Class N | Unknown | No | 2019-03-11 |
| Next Generation Sequencing Based Tumor Profiling Test | PZM | Class 2 | Pathology | No | 2020-04-25 |
| Synthetic Next-Generation Sequencing Quality Control And Filler Material | QFI | Class N | Unknown | No | 2019-02-26 |
| High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids | SBY | Class 2 | Pathology | No | 2024-08-23 |
| Reagents For Molecular Diagnostic Test Systems | PFT | Class 1 | Clinical Chemistry | No | 2020-02-04 |
Proprietary Names
PGDx elio tissue complete
PGDx elio plasma focus Dx
PGDx elio diversiPhi
Establishment Types
Manufacture Device in the United States for Export Only
Manufacture Medical Device