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FDA PMA

Cytomegalovirus (cmv) dna quantitative assay

PMA Number: P110037 · 2024-10-04

ApplicantRoche Molecular Systems, Inc.
Decision Date2024-10-04
PMA NumberP110037
Product CodePAB
Device ClassClass 2
Medical SpecialtyM
Regulation Number21 CFR 8
Advisory CommitteeMI

Device Summary

Cytomegalovirus (cmv) dna quantitative assay 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 2024-10-04. The device is classified under product code PAB. It was reviewed by the MI advisory panel.

Frequently Asked Questions

What is the Cytomegalovirus (cmv) dna quantitative assay?

Cytomegalovirus (cmv) dna quantitative assay is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is Roche Molecular Systems, Inc..

When did Cytomegalovirus (cmv) dna quantitative assay receive FDA 510(k) clearance?

The clearance date for Cytomegalovirus (cmv) dna quantitative assay can be found in the official FDA records.

Who is the listed applicant for Cytomegalovirus (cmv) dna quantitative assay?

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 Cytomegalovirus (cmv) dna quantitative assay?

The FDA product code for Cytomegalovirus (cmv) dna quantitative assay is PAB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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