FDA Registration
Active
🇸🇪 Sweden
Xpert Vaginal/Endocervical Specimen Collection Kit
Reg #: 3009613136
·
FEI: 3009613136
·
Expires 2025
Products
4
Proprietary Names
4
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- CEPHEID AB
- Registration Number
- 3009613136
- FEI Number
- 3009613136
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Rontgenvagen 5
- City
- SOLNA Stockholm
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K190441
Owner / Operator
- Firm Name
- CEPHEID
- Operator Number
- 9062742
- Address
- 904 CARIBBEAN DRIVE, --
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94089
- Country
- US
- Correspondent
- Somesh Lalithraj
US Agent
- Business Name
- CEPHEID
- Contact Name
- Somesh Lalithraj
- Address
- 904 E Caribbean Dr
- City
- Sunnyvale
- State
- CA
- ZIP
- 94089
- Country
- US
- [email protected]
- Phone
- 408 2427416
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Microbial Nucleic Acid Storage And Stabilization Device | QBD | Class 2 | Microbiology | No | 2019-05-23 |
| Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | QEP | Class 2 | Microbiology | No | 2019-05-23 |
| Dna Probe, Nucleic Acid Amplification, Chlamydia | MKZ | Class 1 | Microbiology | No | 2019-05-23 |
| Dna-Reagents, Neisseria | LSL | Class 2 | Microbiology | No | 2019-05-23 |
Proprietary Names
Xpert Vaginal/Endocervical Specimen Collection Kit
Xpert Swab Specimen Collection Kit
Xpert CT/NG
Xpert Urine Specimen Collection Kit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)