FDA Registration
Active
🇺🇸 United States
Rickettsia Spp. Nucleic Acid Based Detection Assay
Reg #: 1050190
·
FEI: 1050190
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CENTERS FOR DISEASE CONTROL AND PREVENTION
- Registration Number
- 1050190
- FEI Number
- 1050190
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1600 CLIFTON RD., N.E.
- City
- ATLANTA
- State
- GA
- ZIP
- 30333
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170940
Owner / Operator
- Firm Name
- U.S. GOVERNMENT DEPARTMENT HHS
- Operator Number
- 1050190
- Address
- 1600 CLIFTON RD., N.E.
- City
- ATL
- State
- GA
- Postal Code
- 30329
- Country
- US
- Correspondent
- DR. DENNIS A BAGAROZZI JR.
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rickettsia Spp. Nucleic Acid Based Detection Assay | PVQ | Class 2 | Microbiology | No | 2020-01-24 |
Proprietary Names
Rickettsia Spp. Nucleic Acid Based Detection Assay
Establishment Types
Manufacture Medical Device