FDA Registration
Active
🇺🇸 United States
CENTERS FOR DISEASE CONTROL AND PREVENTION
Reg #: 1050190
·
FEI: 1050190
·
Expires 2026
Products
16
Proprietary Names
20
Establishment Types
3
Classifications
16
Registration Details
- Registration Name
- CENTERS FOR DISEASE CONTROL AND PREVENTION
- Registration Number
- 1050190
- FEI Number
- 1050190
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1600 CLIFTON RD., N.E.
- City
- ATLANTA
- State
- GA
- ZIP
- 30333
- Country
- US
Regulatory Submissions
- 510(k) Number
- K252072
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 |
|---|---|---|---|---|---|
| Antiserum, Fluorescent, Francisella Tularensis | GSJ | Class 2 | Microbiology | No | 1978-06-28 |
| Antiserum, Vibrio Cholerae, All Varieties | GSQ | Class 2 | Microbiology | No | 1978-06-28 |
| Antiserum, Typhus Fever | GPN | Class 1 | Microbiology | No | 1978-06-28 |
| Biothreat Microbial Agent Nucleic Acid Detection Test | SGA | Class 2 | Immunology | No | 2026-02-05 |
| Rickettsia Spp. Nucleic Acid Based Detection Assay | PVQ | Class 2 | Microbiology | No | 2020-01-24 |
| Antigen, Cf, Spotted Fever Group | GPQ | Class 1 | Microbiology | No | 1978-06-28 |
| Antigen, Cf, Typhus Fever Group | GPO | Class 1 | Microbiology | No | 1978-06-28 |
| Assay, Nucleic Acid Amplification, Bacillus Anthracis | NHT | Class 2 | Microbiology | No | 2020-01-24 |
| Antisera, All Groups, Salmonella Spp. | GRM | Class 2 | Microbiology | No | 1978-06-28 |
| Antigen, Cf, Q Fever | GPS | Class 1 | Microbiology | No | 1978-06-28 |
| Bacteriophage And Controls, B. Anthracis Lysis | NVQ | Class 2 | Microbiology | No | 2017-05-08 |
| Dengue Nucleic Acid Amplification Assay (Naat) | OZB | Class 2 | Microbiology | No | 2015-05-22 |
| Variola Virus Nucleic Acid-Based Detection Assay | PRA | Class 2 | Microbiology | No | 2017-05-08 |
| Antiserum, Cf, Q Fever | GPR | Class 1 | Microbiology | No | 1978-06-28 |
| Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set | PBK | Class 2 | Microbiology | No | 2025-05-12 |
| Influenza A And Influenza B Multiplex Nucleic Acid Assay | OZE | Class 2 | Microbiology | No | 2025-07-28 |
Proprietary Names
ANTISERUM, FLUORESCENT, FRANCISELLA TULARENSIS
ANTISERUM, VIBRIO CHOLERAE, ALL VARIETIES
ANTISERUM, TYPHUS FEVER
Francisella tularensis Real-time PCR Assay
Rickettsia Spp. Nucleic Acid Based Detection Assay
ANTIGEN, CF, SPOTTED FEVER GROUP
ANTIGEN, CF, TYPHUS FEVER GROUP
B. anthracis Real-time PCR Assay
ANTISERA, ALL GROUPS, SALMONELLA SPP.
ANTIGEN, CF, Q FEVER
Gamma Phage Lysis Assay for the Identification of Bacillus anthracis
CDC DENV-1-4 REAL TIME RT-PCT ASSAY
Variola virus Real-time PCR Assay
ANTISERUM, CF, Q FEVER
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Influenza B Genotyping Kit (VER 1.1 and 2)
Influenza A SubTyping Kit (VER 4)
Influenza A/B Typing Kit (VER 2)
Influenza A/H5 Subtyping Kit (VER 4)
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A and Influenza B Multiplex Nucleic Acid Assay
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility