FDA Product Code SBT: Device To Detect Microbial Colonization Directly From Clinical Specimens.
A Device To Detect Microbial Colonization Directly From Clinical Specimens Is A Qualitative In Vitro Diagnostic Device Intended For The Detection And Identification Of Microbial-associated Targets From Patients Who Are Suspected Of Being Colonized With A Microbial Pathogen And May Present A Risk Of Transmission To Other Patients And Health Care Workers. This Device Is Intended To Aid In The Detection Of Microbial Colonizers For The Prevention And Control Of Infection In Healthcare Settings When Used In Conjunction With Clinical And Laboratory Findings.
Leading manufacturers include Diasorin Molecular, LLC.
FDA 510(k) Cleared Device To Detect Microbial Colonization Directly From Clinical Specimens. Devices (Product Code SBT)
About Product Code SBT - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SBT since 2024, with 0 receiving FDA clearance (average review time: 200 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SBT devices are reviewed by the Microbiology panel. Browse all Microbiology devices →