FDA Product Code QUU: Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples
A Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Species (spp.) Is A Prescription In Vitro Diagnostic Device Used To Detect And Presumptively Identify B. Anthracis And Other Bacillus Spp. In Human Clinical Samples As An Aid In The Diagnosis Of Anthrax And Other Diseases Caused By Bacillus Spp. This Device Is Simple To Use And Does Not Involve Sample Manipulation Or Measurement Of An Analyte That Could Be Affected By Conditions Such As Sample Turbidity Or Cell Lysis. This Device May Be Used To Aid In The Presumptive Diagnosis Of Anthrax In Individuals Who Have Signs And Symptoms Consistent With Anthrax And A Likelihood Of Exposure. Bacillus Infections Include Anthrax (cutaneous, Inhalational, Or Gastrointestinal) Caused By B. Anthracis, Gastrointestinal Disease, Non-gastrointestinal Infections, And An Anthrax-like Illness Caused By B. Cereus.
Leading manufacturers include InBios International, Inc. and First Light Diagnostics, Inc..
FDA 510(k) Cleared Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples Devices (Product Code QUU)
About Product Code QUU - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QUU since 2023, with 1 receiving FDA clearance (average review time: 150 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
QUU devices are reviewed by the Microbiology panel. Browse all Microbiology devices →