Device type
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Product code PMN · Class II · 21 CFR 866.3920 · Microbiology
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
Recent 510(k)s
Oct 30, 2026
K263232
eplex RP3 Control M530; eplex RP3 Negative
Maine Molecular Quality Controls, Inc.
- PMN
- Class II
Oct 21, 2026
K262573
SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control
Maine Molecular Quality Controls, Inc.
- PMN
- Class II
Recent recalls
No recalls in the archive for PMN.