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FDA PMA

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

PMA Number: P230003 · 2026-05-15

ApplicantAbbott Molecular, Inc.
Decision Date2026-05-15
PMA NumberP230003
Product CodeMAQ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeMI

Device Summary

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS is a medical device manufactured by Abbott Molecular, Inc.. It received FDA Premarket Approval (PMA) on 2026-05-15 under PMA number P230003. The device is classified under FDA product code MAQ. It was reviewed by the MI advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS?

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS is a medical device that received FDA Premarket Approval (PMA) on 2026-05-15. It is manufactured by Abbott Molecular, Inc.. The PMA number is P230003.

When did KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS receive FDA PMA approval?

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS received FDA PMA approval on 2026-05-15, under approval number P230003.

What company makes KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS?

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS is manufactured by Abbott Molecular, Inc..

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

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

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

What FDA device class is KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS?

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS is classified as Class III by the FDA.

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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