Centers for Disease Control and Prevention
Centers for Disease Control and Prevention holds FDA 510(k) medical device clearances, first cleared 1981, most recent 2026, with 1 FDA device recall on record.
Top product codes for Centers for Disease Control and Prevention
FDA recalls by Centers for Disease Control and Prevention
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Centers for Disease Control and Prevention
- K260812 — Francisella tularensis Real-time PCR Assay
- K252072 — Francisella tularensis Real-time PCR assay
- K243274 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2) +3 more
- K243931 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2) +3 more
- K241110 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
- K222558 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
- K221834 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
- K221658 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
- 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
- K192871 — B. anthracis Real-time PCR Assay
- 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
- DEN070001 — NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
- K181205 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
- 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
- K141859 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING
- K140851 — INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- K140857 — INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- K132508 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- DEN130005 — QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
- K130551 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- K123905 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- DEN120012 — CDC DENV-1-4 REAL TIME RT-PCT ASSAY
- K111507 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- K101564 — CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL
- K080570 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL
- DEN060008 — INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET
- K993633 — SYNTHETIC VDRL ANTIGEN
- K820945 — SERA FOR ANTINUCLEAR ANTIBODIES
- K812006 — LEGIONELLA DIRECT FLUORESCENT ANTIBODY
- K812007 — LEGIONELLA INDIRECT FLUOR. ANTIBODY
Data sourced from openFDA. This site is unofficial and independent of the FDA.