Data / Medical devices / United States / Centers For Disease Control And Prevention
Centers For Disease Control And Prevention: FDA-registered device maker in Atlanta, GA, United States, 7 510(k) clearances
Centers For Disease Control And Prevention is registered with the FDA (registration 1050190) in Atlanta, GA, United States. It lists 15 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 30, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1050190
- Address
- 1600 Clifton RD., N.E., Atlanta, GA, United States, 30333
- Owner or operator
- U.S. GOVERNMENT DEPARTMENT HHS (1050190)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 28, 1978
- Registered through
- 2026
- Brand names listed
- ANTIGEN, CF, Q FEVER, ANTIGEN, CF, SPOTTED FEVER GROUP, ANTIGEN, CF, TYPHUS FEVER GROUP, ANTISERA, ALL GROUPS, SALMONELLA SPP., ANTISERUM, CF, Q FEVER, ANTISERUM, FLUORESCENT, FRANCISELLA TULARENSIS, ANTISERUM, TYPHUS FEVER, ANTISERUM, VIBRIO CHOLERAE, ALL VARIETIES and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigen, Cf, Q Fever | GPS | 1 | Manufacturer | accessdata.fda.gov |
| Antigen, Cf, Spotted Fever Group | GPQ | 1 | Manufacturer | accessdata.fda.gov |
| Antigen, Cf, Typhus Fever Group | GPO | 1 | Manufacturer | accessdata.fda.gov |
| Antisera, All Groups, Salmonella Spp. | GRM | 2 | Manufacturer | accessdata.fda.gov |
| Antiserum, Cf, Q Fever | GPR | 1 | Manufacturer | accessdata.fda.gov |
| Antiserum, Fluorescent, Francisella Tularensis | GSJ | 2 | Manufacturer | accessdata.fda.gov |
| Antiserum, Typhus Fever | GPN | 1 | Manufacturer | accessdata.fda.gov |
| Antiserum, Vibrio Cholerae, All Varieties | GSQ | 2 | Manufacturer | accessdata.fda.gov |
| Assay, Nucleic Acid Amplification, Bacillus Anthracis | NHT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Bacteriophage And Controls, B. Anthracis Lysis | NVQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Biothreat Microbial Agent Nucleic Acid Detection Test | SGA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Dengue Nucleic Acid Amplification Assay (Naat) | OZB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Influenza A And Influenza B Multiplex Nucleic Acid Assay | OZE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set | PBK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Variola Virus Nucleic Acid-Based Detection Assay | PRA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 30, 2026 | K260812 | Francisella tularensis Real-time PCR Assay | SGA | Substantially Equivalent | Centers for Disease Control and Prevention | accessdata.fda.gov |
| July 11, 2025 | K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) | OZE | Substantially Equivalent | Centers for Disease Control and Prevention | accessdata.fda.gov |
| August 30, 2022 | K222558 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | PBK | Substantially Equivalent | Centers for Disease Control and Prevention | accessdata.fda.gov |
| November 7, 2019 | K192871 | B. anthracis Real-time PCR Assay | NHT | Substantially Equivalent | Centers for Disease Control and Prevention | accessdata.fda.gov |
| February 6, 2017 | DEN160016 | Variola virus Real-Time PCR Assay | PRA | Unknown | Centers For Disease Control and Prevention (CDC) | accessdata.fda.gov |
| April 16, 2015 | K143592 | GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC | NVQ | Substantially Equivalent | The Surgeon General, Department of the Army | accessdata.fda.gov |
| May 24, 2012 | DEN120012 | CDC DENV-1-4 REAL TIME RT-PCT ASSAY | OZB | Unknown | Centers for Disease Control and Prevention | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 26, 2024 | 94739 | Class II | Terminated | CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11 | The H5b component may fail to amplify, resulting in an inconclusive result. | accessdata.fda.gov |
Compare with other makers
Updated March 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.