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FDA PMA

Hepatitis Viral B DNA Detection

PMA Number: P170025 · 2025-10-07

ApplicantHologic, Inc.
Decision Date2025-10-07
PMA NumberP170025
Product CodeMKT
Device ClassClass 2
Medical SpecialtyM
Regulation Number21 CFR 8
Advisory CommitteeMI

Device Summary

Hepatitis Viral B DNA Detection is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2025-10-07. The device is classified under product code MKT. It was reviewed by the MI advisory panel.

Frequently Asked Questions

What is the Hepatitis Viral B DNA Detection?

Hepatitis Viral B DNA Detection is a medical device that received FDA 510(k) clearance on 2025-10-07. The listed applicant is Hologic, Inc..

When did Hepatitis Viral B DNA Detection receive FDA 510(k) clearance?

The clearance date for Hepatitis Viral B DNA Detection can be found in the official FDA records.

Who is the listed applicant for Hepatitis Viral B DNA Detection?

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

What is the FDA product code for Hepatitis Viral B DNA Detection?

The FDA product code for Hepatitis Viral B DNA Detection is MKT.

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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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