FDA Product Code SGA: Biothreat Microbial Agent Nucleic Acid Detection Test
A Biothreat Microbial Agent Nucleic Acid Detection Test Is A Qualitative In Vitro Diagnostic Device For The Detection And Identification Of Biothreat Microbial Agentassociated Nucleic Acids In Human Clinical Specimens.
Leading manufacturers include Centers For Disease Control and Prevention.
1
Total
1
Cleared
91d
Avg days
2025
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Biothreat Microbial Agent Nucleic Acid Detection Test Devices (Product Code SGA)
1 devices
About Product Code SGA - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SGA since 2025, with 1 receiving FDA clearance (average review time: 91 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.