PMN · Class II · 21 CFR 866.3920

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 Maine Molecular Quality Controls, Inc., Microbiologics, Inc. and Streck.

31
Total
30
Cleared
137d
Avg days
2016
Since
31 devices
25–31 of 31
Cleared Aug 28, 2018
BD MAX CT/GC/TV 20-Day QC Panel
K181683
Microbiologics, Inc.
Microbiology · 63d
Cleared Aug 15, 2018
BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
K181711
Microbiologics, Inc.
Microbiology · 48d