FDA Product Code QBX: Direct Blood Bacterial Nucleic Acid Detection System
Amplification, Detection And Identification Of Microbial Pathogens Directly From Whole Blood Specimens
Leading manufacturers include T2biosystems, Inc..
2
Total
2
Cleared
196d
Avg days
2018
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Direct Blood Bacterial Nucleic Acid Detection System Devices (Product Code QBX)
2 devices
About Product Code QBX - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QBX since 2018, with 2 receiving FDA clearance (average review time: 196 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QBX devices are reviewed by the Microbiology panel. Browse all Microbiology devices →