FDA 510(k)

Alinity m CMV

K-Number: K243485 · 2025-07-01

Decision Date2025-07-01

Product CodePAB

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Alinity m CMV is a medical device manufactured by Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2025-07-01 under approval number K243485. 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 Alinity m CMV?

Alinity m CMV is a medical device that received FDA 510(k) clearance on 2025-07-01. It is manufactured by Abbott Molecular, Inc.. The 510(k) number is K243485.

When was Alinity m CMV approved by the FDA?

Alinity m CMV received FDA 510(k) clearance on 2025-07-01, under approval number K243485.

What company makes Alinity m CMV?

Alinity m CMV is manufactured by Abbott Molecular, Inc..

What is the FDA product code for Alinity m CMV?

The FDA product code for Alinity m CMV is PAB.

Other Devices by Abbott Molecular, Inc.

K212778Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) K202977Alinity m STI Assay K222379Alinity m STI Assay K233349Alinity m HSV 1 & 2 / VZV K252102Alinity m HCV K243489Alinity m EBV (09N43-095)

View all 20 devices →

Related Devices (Code: PAB)

K252481cobas CMVRoche Molecular Systems, 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.