Centers for Disease Control and Prevention
Atlanta, GA, US
CENTERS FOR DISEASE CONTROL AND PREVENTION appears in FDA device records in Atlanta, GA. FDA records list 30 510(k) clearances between and , one PMA record and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 30 510(k) clearances for Centers for Disease Control and Prevention between 1981 and 2026. The busiest year on record is 2013, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 2 |
| 1982 | 1 |
| 2000 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 4 |
| 2014 | 3 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2022 | 3 |
| 2024 | 1 |
| 2025 | 3 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260812 | Francisella tularensis Real-time PCR Assay | SGA | Substantially Equivalent | |
| K252072 | Francisella tularensis Real-time PCR assay | SGA | Substantially Equivalent | |
| 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 | |
| K243931 | 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 Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) | OZE | Substantially Equivalent | |
| K241110 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) | OZE | Substantially Equivalent | |
| K222558 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | PBK | Substantially Equivalent | |
| K221834 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | PBK | Substantially Equivalent | |
| K221658 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | PBK | Substantially Equivalent | |
| K200370 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit | OZE | Substantially Equivalent | |
| K192871 | B. anthracis Real-time PCR Assay | NHT | Substantially Equivalent | |
| K190302 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit | OZE | Substantially Equivalent | |
| DEN070001 | NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET | PBK | Unknown | |
| K181205 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | PBK | Substantially Equivalent | |
| K172091 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit | OZE | Substantially Equivalent | |
| K141859 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING | OZE | Substantially Equivalent | |
| K140857 | INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | OZE | Substantially Equivalent | |
| K140851 | INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | OEP | Substantially Equivalent | |
| K132508 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | OZE | Substantially Equivalent | |
| DEN130005 | QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS | PDY | Unknown | |
| K130551 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | OQW | Substantially Equivalent | |
| K123905 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | OQW | Substantially Equivalent | |
| DEN120012 | CDC DENV-1-4 REAL TIME RT-PCT ASSAY | OZB | Unknown | |
| K111507 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | OQW | Substantially Equivalent | |
| K101564 | CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL | OQW | Substantially Equivalent | |
| K080570 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL | NXD | Substantially Equivalent | |
| DEN060008 | INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET | NXD | Unknown | |
| K993633 | SYNTHETIC VDRL ANTIGEN | GMQ | Substantially Equivalent | |
| K820945 | SERA FOR ANTINUCLEAR ANTIBODIES | DHN | Substantially Equivalent | |
| K812007 | LEGIONELLA INDIRECT FLUOR. ANTIBODY | LHL | Substantially Equivalent | |
| K812006 | LEGIONELLA DIRECT FLUORESCENT ANTIBODY | LHL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1050190 | 1050190 | CENTERS FOR DISEASE CONTROL AND PREVENTION | 1600 CLIFTON RD., N.E., ATLANTA, GA 30333 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OQW2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
- GPSAntigen, Cf, Q Fever
- GPQAntigen, Cf, Spotted Fever Group
- GPOAntigen, Cf, Typhus Fever Group
- GMQAntigens, Nontreponemal, All
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- GRMAntisera, All Groups, Salmonella Spp.
- GPRAntiserum, Cf, Q Fever
- GSJAntiserum, Fluorescent, Francisella Tularensis
- GPNAntiserum, Typhus Fever
- GSQAntiserum, Vibrio Cholerae, All Varieties
- NHTAssay, Nucleic Acid Amplification, Bacillus Anthracis
- NVQBacteriophage And Controls, B. Anthracis Lysis
- SGABiothreat Microbial Agent Nucleic Acid Detection Test
- LTQCalibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum
- OZBDengue Nucleic Acid Amplification Assay (Naat)
- OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay
- OEPInfluenza A Virus Subtype Differentiation Nucleic Acid Assay
- PBKNon-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
- NXDNucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
- PDYOrganophosphate Test System
- LHLReagents, Antibody, Legionella, Direct & Indirect Fluorescent
- PRAVariola Virus Nucleic Acid-Based Detection Assay
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2220-2024 | CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11 | The H5b component may fail to amplify, resulting in an inconclusive result. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain