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FDA PMA

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

PMA Number: P100020 · 2026-03-17

ApplicantRoche Molecular Systems, Inc.
Decision Date2026-03-17
PMA NumberP100020
Product CodeMAQ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeMI

Device Summary

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2026-03-17. The device is classified under product code MAQ. It was reviewed by the MI advisory panel.

Frequently Asked Questions

What is the KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS?

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS is a medical device that received FDA 510(k) clearance on 2026-03-17. The listed applicant is Roche Molecular Systems, Inc..

When did KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS receive FDA 510(k) clearance?

The clearance date for KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS can be found in the official FDA records.

Who is the listed applicant for KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS?

The FDA 510(k) record lists Roche Molecular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS?

The FDA product code for KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS is MAQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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