Centers For Disease Control and Prevention

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
29
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2220-2024Class IICDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11April 26, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K252072Francisella tularensis Real-time PCR assaySeptember 30, 2025
K243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); InfluJuly 11, 2025
K243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); InfluMarch 14, 2025
K241110CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)May 21, 2024
K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetAugust 30, 2022
K221834Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetJune 24, 2022
K221658Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetJune 10, 2022
K200370CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human InfMarch 10, 2020
K192871B. anthracis Real-time PCR AssayNovember 7, 2019
K190302CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human InfMarch 27, 2019
DEN070001NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SETSeptember 21, 2018
K181205Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetSeptember 20, 2018
K172091CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human InfAugust 9, 2017
K141859CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPINGAugust 1, 2014
K140851INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELApril 25, 2014
K140857INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELApril 25, 2014
K132508CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELSeptember 23, 2013
DEN130005QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MSAugust 8, 2013
K130551CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELMay 22, 2013
K123905CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELJanuary 14, 2013