FDA Product Code PMN: Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
Assayed External Quality Control Material To Monitor The Performance Of Microbiology Nucleic Acid Assays For In Vitro Diagnostic Use.
Leading manufacturers include Streck.
2
Total
2
Cleared
90d
Avg days
2023
Since
List of Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays devices cleared through 510(k)
2 devices
Cleared
Jul 27, 2023
MDx-Chex for BC-GP
Streck
Microbiology
90d
Cleared
Jul 27, 2023
MDx-Chex for BC-GN
Streck
Microbiology
90d
How to use this database
This page lists all FDA 510(k) submissions for Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays devices (product code PMN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →