FDA Registration
Active
🇺🇸 United States
Luminex Corporation
Reg #: 3006028115
·
FEI: 3006028115
·
Expires 2026
Products
18
Proprietary Names
10
Establishment Types
2
Classifications
18
Registration Details
- Registration Name
- Luminex Corporation
- Registration Number
- 3006028115
- FEI Number
- 3006028115
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4088 Commercial Avenue
- City
- Northbrook
- State
- IL
- ZIP
- 60062
- Country
- US
Regulatory Submissions
- 510(k) Number
- K132843
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 |
|---|---|---|---|---|---|
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2016-08-16 |
| Gram-Negative Bacteria And Associated Resistance Markers | PEN | Class 2 | Microbiology | No | 2016-08-16 |
| 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 |
| Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | QOF | Class 2 | Microbiology | No | 2024-05-15 |
| Respiratory Virus Panel Nucleic Acid Assay System | OCC | Class 2 | Microbiology | No | 2024-05-15 |
| Human Metapneumovirus (Hmpv) Rna Assay System | OEM | Class 2 | Microbiology | No | 2024-05-15 |
| Non-Sars Coronavirus Multiplex Nucleic Acid Assay | OTG | Class 2 | Microbiology | No | 2024-05-15 |
| Influenza A And Influenza B Multiplex Nucleic Acid Assay | OZE | Class 2 | Microbiology | No | 2024-05-15 |
| Mycoplasma Pneumoniae Dna Assay System | OZX | Class 2 | Microbiology | No | 2024-05-15 |
| Parainfluenza Multiplex Nucleic Acid Assay | OOU | Class 2 | Microbiology | No | 2024-05-15 |
| Bordetella Pertussis Dna Assay System | OZZ | Class 2 | Microbiology | No | 2024-05-15 |
| Chlamydophila Pneumoniae Dna Assay System | OZY | Class 2 | Microbiology | No | 2024-05-15 |
| Gram-Positive Bacteria And Their Resistance Markers | PAM | Class 2 | Microbiology | No | 2025-07-07 |
| Fungal Organisms, Nucleic Acid-Based Assay | PEO | Class 2 | Microbiology | No | 2024-10-16 |
| Influenza A Virus Subtype Differentiation Nucleic Acid Assay | OEP | Class 2 | Microbiology | No | 2016-08-16 |
| C. Difficile Toxin Gene Amplification Assay | OZN | Class 2 | Microbiology | No | 2016-08-16 |
Proprietary Names
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)
Verigene Enteric Pathogens Nucleic Acid Test (EP); Verigene EP
LIAISON PLEX Respiratory Flex Assay
LIAISON PLEX Gram-Negative Blood Culture Assay
LIAISON PLEX® Gram-Positive Blood Culture Assay
LIAISON PLEX Yeast Blood Culture Assay
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
LIAISON PLEX Gastrointestinal Flex Assay
Verigene System
Verigene CDF Nucleic Acid Test
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198