FDA Registration
Active
🇺🇸 United States
Xpert Urine Specimen Collection kit
Reg #: 3016838963
·
FEI: 3016838963
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Cepheid
- Registration Number
- 3016838963
- FEI Number
- 3016838963
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 121 N Guild Ave
- City
- Lodi
- State
- CA
- ZIP
- 95240
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161619
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 |
|---|---|---|---|---|---|
| Trichomonas Vaginalis Nucleic Acid Amplification Test System | OUY | Class 2 | Immunology | No | 2024-12-11 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2024-12-11 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2024-12-11 |
Proprietary Names
Xpert Urine Specimen Collection kit
Xpert TV
Establishment Types
Manufacture Medical Device