FDA Registration
Active
🇺🇸 United States
Verigene System
Reg #: 3006028115
·
FEI: 3006028115
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
2
Classifications
7
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
- K143653
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 |
|---|---|---|---|---|---|
| Influenza A Virus Subtype Differentiation Nucleic Acid Assay | OEP | Class 2 | Microbiology | No | 2016-08-16 |
| Influenza A And Influenza B Multiplex Nucleic Acid Assay | OZE | Class 2 | Microbiology | No | 2016-08-16 |
| Human Metapneumovirus (Hmpv) Rna Assay System | OEM | Class 2 | Microbiology | No | 2016-08-16 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2016-08-16 |
| Parainfluenza Multiplex Nucleic Acid Assay | OOU | Class 2 | Microbiology | No | 2016-08-16 |
| Bordetella Pertussis Dna Assay System | OZZ | Class 2 | Microbiology | No | 2016-08-16 |
| Respiratory Virus Panel Nucleic Acid Assay System | OCC | Class 2 | Microbiology | No | 2016-08-16 |
Proprietary Names
Verigene System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device