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FDA PMA

Hepatitis Viral B DNA Detection

PMA Number: P150014 · 2025-10-17

ApplicantRoche Molecular Systems, Inc.
Decision Date2025-10-17
PMA NumberP150014
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 Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-10-17. 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 2025-10-17. The listed applicant is Roche Molecular Systems, 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 Roche Molecular Systems, 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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