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FDA PMA

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus

PMA Number: P160023 · 2020-07-21

ApplicantHologic, Inc.
Decision Date2020-07-21
PMA NumberP160023
Product CodeMZP
Device ClassClass 2
Medical SpecialtyM
Regulation Number21 CFR 8
Advisory CommitteeMI

Device Summary

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2020-07-21. The device is classified under product code MZP. It was reviewed by the MI advisory panel.

Frequently Asked Questions

What is the Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus?

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is a medical device that received FDA 510(k) clearance on 2020-07-21. The listed applicant is Hologic, Inc..

When did Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus receive FDA 510(k) clearance?

The clearance date for Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus can be found in the official FDA records.

Who is the listed applicant for Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus?

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 Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus?

The FDA product code for Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is MZP.

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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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