FDA 510(k)

cobas CMV

K-Number: K252481 · 2025-11-03

Decision Date2025-11-03

Product CodePAB

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

cobas CMV is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-11-03 under approval number K252481. The device is classified under product code PAB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas CMV?

cobas CMV is a medical device that received FDA 510(k) clearance on 2025-11-03. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K252481.

When was cobas CMV approved by the FDA?

cobas CMV received FDA 510(k) clearance on 2025-11-03, under approval number K252481.

What company makes cobas CMV?

cobas CMV is manufactured by Roche Molecular Systems, Inc..

What is the FDA product code for cobas CMV?

The FDA product code for cobas CMV is PAB.

Other Devices by Roche Molecular Systems, Inc.

K171770cobas Cdiff Nucleic acid test for use on the cobas Liat System K163184cobas® CT/NG v2.0 Test K173887cobas CT/NG for use on cobas 6800/8800 systems K172913cobas Factor II and Factor V Test DEN190016cobas vivoDx MRSA K191729Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System

View all 47 devices →

Related Devices (Code: PAB)

K243485Alinity m CMVAbbott Molecular, Inc. K243935Aptima CMV Quant AssayHologic, Inc. PMA P110037Cytomegalovirus (cmv) dna quantitative assayRoche Molecular Systems, Inc. PMA P160041Cytomegalovirus (cmv) dna quantitative assayRoche Molecular Systems, Inc. PMA P130027Cytomegalovirus (cmv) dna quantitative assayQiagen, Inc. PMA P160044Cytomegalovirus (cmv) dna quantitative assayAbbott Molecular

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.