FDA Registration
Active
🇺🇸 United States
GENEXPERT DX SYSTEM
Reg #: 3007867838
·
FEI: 1000161215
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Sanmina
- Registration Number
- 3007867838
- FEI Number
- 1000161215
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2700 N 1st St
- City
- SAN JOSE
- State
- CA
- ZIP
- 95134
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173263
Owner / Operator
- Firm Name
- Sanmina Corporation
- Operator Number
- 2129538
- Address
- 13000 S. Memorial Pkwy, --
- City
- Huntsville
- State
- AL
- Postal Code
- 35803
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony | PMY | Class 2 | Microbiology | No | 2018-07-11 |
| System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen | POC | Class 2 | Microbiology | No | 2018-07-11 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2018-07-11 |
Proprietary Names
GENEXPERT DX SYSTEM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)