← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

MAQKit, Dna Detection, Human Papillomavirus

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
MI
ImplantLife-sustainingGMP-exemptThird-party review eligible
4
510(K)/PMA CLEARANCES
pma: 4
0
RECALL ENTRIES

Recent clearances

P230003Abbott Molecular, Inc. · pma2026-06-22
P190028Roche Molecular Systems, Inc. · pma2026-06-16
P160037Becton, Dickinson and Company · pma2026-04-02
P100020Roche Molecular Systems, Inc. · pma2026-03-17

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →