FDA Registration
Active
🇺🇸 United States
GeneXpert Xpress System
Reg #: 3004530258
·
FEI: 3004530258
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CEPHEID
- Registration Number
- 3004530258
- FEI Number
- 3004530258
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 904 CARIBBEAN DRIVE
- City
- Sunnyvale
- State
- CA
- ZIP
- 94089
- Country
- US
Owner / Operator
- Firm Name
- CEPHEID
- Operator Number
- 9062742
- Address
- 904 CARIBBEAN DRIVE, --
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94089
- Country
- US
- Correspondent
- Somesh Lalithraj
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2024-12-12 |
Proprietary Names
GeneXpert Xpress System
GeneXpert DX systems
GeneXpert system with Touchscreen
GeneXpert Infinity Systems
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device