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FDA PRODUCT CODE · CLASS III

OWD — Somatic Gene Mutation Detection System

The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
PA
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
10
510(K)/PMA CLEARANCES
pma: 10
0
RECALL ENTRIES

Recent clearances

P170041Abbott Molecular, Inc. · pma2026-05-28
P170005Abbott Molecular, Inc. · pma2026-05-28
P180043QIAGEN GmbH · pma2026-05-06
P200014Roche Molecular System, Inc. · pma2026-03-17
P120019Roche · pma2026-03-17
P140023Roche Molecular Systems, Inc. · pma2026-03-17
P110020Roche Molecular Systems, Inc. · pma2026-03-17
P190001QIAGEN GmbH · pma2025-10-22

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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