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

Cleared Sep 30, 2025

Francisella tularensis Real-time PCR assay

K252072 · SGA

Microbiology · 91d

Cleared Jul 11, 2025

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

K243274 · OZE

Microbiology · 268d

Cleared Mar 14, 2025

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

K243931 · OZE

Microbiology · 84d

Cleared May 21, 2024

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

K241110 · OZE

Microbiology · 29d

Cleared Aug 30, 2022

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

K222558 · PBK

Microbiology · 6d

Cleared Jun 24, 2022

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

K221834 · PBK

Microbiology · 1d

Cleared Jun 10, 2022

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

K221658 · PBK

Microbiology · 2d

Cleared Mar 10, 2020

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

K200370 · OZE

Microbiology · 25d

Cleared Nov 07, 2019

B. anthracis Real-time PCR Assay

K192871 · NHT

Microbiology · 30d

Cleared Mar 27, 2019

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

K190302 · OZE

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

K181205 · PBK

Microbiology · 136d