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FDA PRODUCT CODE · CLASS II

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 866.3920
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES

Recent clearances

K261475Biofire Defense, LLC · 510k2026-07-17
K260577Maine Molecular Quality Controls, Inc. · 510k2026-05-19
K260041Streck, LLC · 510k2026-03-27
K254166Streck · 510k2026-03-23
K254167Streck, LLC · 510k2026-03-17
K251526Maine Molecular Quality Controls, Inc. · 510k2025-08-14

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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