FDA Registration
Active
🇺🇸 United States
Verigene Enteric Pathogens Nucleic Acid Test (EP); Verigene EP
Reg #: 3006028115
·
FEI: 3006028115
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Luminex Corporation
- Registration Number
- 3006028115
- FEI Number
- 3006028115
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4088 Commercial Avenue
- City
- Northbrook
- State
- IL
- ZIP
- 60062
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140083
Owner / Operator
- Firm Name
- Luminex Corporation
- Operator Number
- 9032042
- Address
- 12212 Technology Blvd.
- City
- Austin
- State
- TX
- Postal Code
- 78727
- Country
- US
- Correspondent
- Mari Meyer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2016-08-16 |
| Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | PCH | Class 2 | Microbiology | No | 2016-08-16 |
| Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System | PCI | Class 2 | Microbiology | No | 2016-08-16 |
Proprietary Names
Verigene Enteric Pathogens Nucleic Acid Test (EP); Verigene EP
Establishment Types
Manufacture Medical Device