FDA Product Code MDB: System, Blood Culturing
Leading manufacturers include Becton, Dickinson and Company.
67
Total
67
Cleared
122d
Avg days
1981
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared System, Blood Culturing Devices (Product Code MDB)
67 devices
Cleared
Mar 24, 2023
BD BACTEC™ Myco/F Lytic Culture Vials
Becton, Dickinson and Company
Microbiology
212d
Cleared
Mar 24, 2023
BD BACTEC™ Plus Aerobic/F Culture Vials
Becton, Dickinson and Company
Microbiology
210d
About Product Code MDB - Regulatory Context
510(k) Submission Activity
67 total 510(k) submissions under product code MDB since 1981, with 67 receiving FDA clearance (average review time: 122 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
MDB devices are reviewed by the Microbiology panel. Browse all Microbiology devices →