FDA Registration
Active
🇺🇸 United States
Gastrointestinal Pathogen Panel (GPP)
Reg #: 1650733
·
FEI: 3002524000
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Luminex Corporation
- Registration Number
- 1650733
- FEI Number
- 3002524000
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12212 Technology Blvd
- City
- AUSTIN
- State
- TX
- ZIP
- 78727
- Country
- US
Regulatory Submissions
- 510(k) Number
- K121894
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 |
|---|---|---|---|---|---|
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2013-05-13 |
| Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | PCH | Class 2 | Microbiology | No | 2013-05-13 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2013-05-13 |
Proprietary Names
Gastrointestinal Pathogen Panel (GPP)
Establishment Types
Manufacture Medical Device