Medical Device Manufacturer · US , Atlanta , GA

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

6 submissions · 5 cleared · Since 2014

Recent clearances: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,, Rickettsia Real-time PCR Assay, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit

6

Total

5

Cleared

1

Denied

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

6 devices

1-6 of 6

Cleared Jul 30, 2018

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

Microbiology · 28d

Cleared Jun 29, 2017

Rickettsia Real-time PCR Assay

Microbiology · 91d

Not Cleared Feb 06, 2017

Variola virus Real-Time PCR Assay

DEN160016 · PRA

Microbiology · 298d

Cleared Jun 30, 2016

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

Microbiology · 24d

Cleared Dec 01, 2015

CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5...

Microbiology · 32d

Cleared May 22, 2014

ANTHRACIS REAL-TIME PCR ASSAY

Microbiology · 92d