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Aptima CMV Quant Assay

by Hologic, Inc.

PMA P210029510(k) K243935

Active United States

PMA 510(k)

Valid until

No expiry

FDA authorization is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK243935 Date17 Jan 2025ClearedStatusActive
United StatesFDA PMA PMA NumberP210029 Date9 May 2022ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k), FDA PMA Active

Specification

510(k) · PMA

Generic name
Cytomegalovirus (cmv) dna quantitative assay
PMA number
510(k) Number
FDA product code
PAB
Device class
Class II
Regulation
21 CFR Part 866.3180
Advisory committee
Microbiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aptima CMV Quant Assay is an in vitro nucleic acid amplification test for the quantitation of human cytomegalovirus (CMV) DNA in human EDTA plasma on the fully automated Panther system. It is intended for use to aid in the management of solid-organ transplant patients and hematopoietic stem cell transplant patients.

In patients receiving anti-CMV therapy, serial DNA measurements can be used to assess viral response to treatment. The results must be interpreted within the context of all relevant clinical and laboratory findings, and the assay is not intended for use as a screening assay for the presence of CMV in blood or blood products.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Aptima CMV Quant Assay used for?

    The Aptima CMV Quant Assay is an in vitro nucleic acid amplification test that quantifies human cytomegalovirus (CMV) DNA in human EDTA plasma. It aids in managing solid-organ transplant patients and hematopoietic stem cell transplant patients, and can assess viral response to anti-CMV therapy through serial DNA measurements.

  • How is the Aptima CMV Quant Assay supplied?

    The Aptima CMV Quant Assay is designed for use on the fully automated Panther system. The device is manufactured by Hologic, Inc. and is supplied as an in vitro nucleic acid amplification test for quantitation of CMV DNA in human EDTA plasma.

  • Is the Aptima CMV Quant Assay intended for screening CMV in blood or blood products?

    No, the Aptima CMV Quant Assay is not intended for use as a screening assay for the presence of CMV in blood or blood products. It is specifically designed for quantitation of CMV DNA in human EDTA plasma for transplant patient management.

  • What regulatory approvals does the Aptima CMV Quant Assay have?

    The Aptima CMV Quant Assay has received FDA 510(k) clearance and FDA PMA approval. It is classified as a Class II device with product code PAB and is intended for use on the Panther system.