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FDA PMA

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

PMA Number: P000012 · 2016-08-04

ApplicantRoche Molecular Systems, Inc.
Decision Date2016-08-04
PMA NumberP000012
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 Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2016-08-04. 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 2016-08-04. The listed applicant is Roche Molecular Systems, 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 Roche Molecular Systems, 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

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

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