Medical Device Manufacturer · US , Mchenry , IL

Centers For Disease Control and Prevention - FDA 510(k) Cleared Devic...

29 submissions · 25 cleared · Since 1981

Recent clearances: Francisella tularensis Real-time PCR assay, CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2), CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2)

29

Total

25

Cleared

4

Denied

FDA 510(k) Regulatory Record - Centers For Disease Control and Prevention Microbiology ✕

28 devices

1-12 of 28

Cleared Sep 30, 2025

Francisella tularensis Real-time PCR assay

Microbiology · 91d

Cleared Jul 11, 2025

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B...

Microbiology · 268d

Cleared Mar 14, 2025

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B...

Microbiology · 84d

Cleared May 21, 2024

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A...

Microbiology · 29d

Cleared Aug 30, 2022

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

Microbiology · 6d

Cleared Jun 24, 2022

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

Microbiology · 1d

Cleared Jun 10, 2022

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

Microbiology · 2d

Cleared Mar 10, 2020

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B...

Microbiology · 25d

Cleared Nov 07, 2019

B. anthracis Real-time PCR Assay

Microbiology · 30d

Cleared Mar 27, 2019

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B...

Microbiology · 43d

Not Cleared Sep 21, 2018

NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET

DEN070001 · PBK

Microbiology · 4266d

Cleared Sep 20, 2018

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

Microbiology · 136d