Company ยท US
Centers for Disease Control and Prevention
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2026. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (3 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | 11 |
| PBK | Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set | 5 |
| OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | 4 |
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 |
| NHT | Assay, Nucleic Acid Amplification, Bacillus Anthracis | 2 |
| NXD | Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna | 2 |
| SGA | Biothreat Microbial Agent Nucleic Acid Detection Test | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| GMQ | Antigens, Nontreponemal, All | 1 |
| OEP | Influenza A Virus Subtype Differentiation Nucleic Acid Assay | 1 |
| OZB | Dengue Nucleic Acid Amplification Assay (Naat) | 1 |
| PDY | Organophosphate Test System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 2026 | K262368 | B. anthracis Real-time PCR Assay Centers for Disease Control and Prevention | NHT |
| Sep 30, 2026 | K263035 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Ki Centers for Disease Control and Prevention | OZE |
| Mar 30, 2026 | K260812 | Francisella tularensis Real-time PCR Assay Centers for Disease Control and Prevention | SGA |
| Sep 30, 2025 | K252072 | Francisella tularensis Real-time PCR assay Centers for Disease Control and Prevention | SGA |
| Jul 11, 2025 | K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit Centers for Disease Control and Prevention | OZE |
| Mar 14, 2025 | K243931 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit Centers for Disease Control and Prevention | OZE |
| May 21, 2024 | K241110 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) Centers for Disease Control and Prevention | OZE |
| Aug 30, 2022 | K222558 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set Centers for Disease Control and Prevention | PBK |
| Jun 24, 2022 | K221834 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set Centers for Disease Control and Prevention | PBK |
| Jun 10, 2022 | K221658 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set Centers for Disease Control and Prevention | PBK |
| Mar 10, 2020 | K200370 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-ti Centers for Disease Control and Prevention | OZE |
| Nov 7, 2019 | K192871 | B. anthracis Real-time PCR Assay Centers for Disease Control and Prevention | NHT |
| Mar 27, 2019 | K190302 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-ti Centers for Disease Control and Prevention | OZE |
| Sep 21, 2018 | DEN070001 | NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET Centers for Disease Control and Prevention | PBK |
| Sep 20, 2018 | K181205 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set Centers for Disease Control and Prevention | PBK |
| Aug 9, 2017 | K172091 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-ti Centers for Disease Control and Prevention | OZE |
| Aug 1, 2014 | K141859 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING Centers for Disease Control and Prevention | OZE |
| Apr 25, 2014 | K140857 | INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL Centers for Disease Control and Prevention | OZE |
| Apr 25, 2014 | K140851 | INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL Centers for Disease Control and Prevention | OEP |
| Sep 23, 2013 | K132508 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL Centers for Disease Control and Prevention | OZE |
| Aug 8, 2013 | DEN130005 | QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS Centers for Disease Control and Prevention | PDY |
| May 22, 2013 | K130551 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL Centers for Disease Control and Prevention | OQW |
| Jan 14, 2013 | K123905 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL Centers for Disease Control and Prevention | OQW |
| May 24, 2012 | DEN120012 | CDC DENV-1-4 REAL TIME RT-PCT ASSAY Centers for Disease Control and Prevention | OZB |
| Aug 23, 2011 | K111507 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL Centers for Disease Control and Prevention | OQW |
| Jun 22, 2010 | K101564 | CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL Centers for Disease Control and Prevention | OQW |
| Sep 30, 2008 | K080570 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL Centers for Disease Control and Prevention | NXD |
| Feb 3, 2006 | DEN060008 | INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET Centers for Disease Control and Prevention | NXD |
| Feb 23, 2000 | K993633 | SYNTHETIC VDRL ANTIGEN Centers for Disease Control and Prevention | GMQ |
| Oct 26, 1982 | K820945 | SERA FOR ANTINUCLEAR ANTIBODIES Centers for Disease Control and Prevention | DHN |
| Sep 8, 1981 | K812007 | LEGIONELLA INDIRECT FLUOR. ANTIBODY Centers for Disease Control and Prevention | LHL |
| Sep 8, 1981 | K812006 | LEGIONELLA DIRECT FLUORESCENT ANTIBODY Centers for Disease Control and Prevention | LHL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2024 | Centers For Disease Control and Prevention CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11 Terminated |
OZE | K200370 |