Product code PAB— Microbiology

Alinity m CMV

Classification name: Cytomegalovirus (Cmv) Dna Quantitative Assay
Device class: Class 2
Regulation: 21 CFR 866.3180
Advisory panel: Microbiology
Total cleared: 3
First cleared: 2025-01-17
Most recent: 2025-11-03

FDA classification definition

“Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma. The assay can be used to measure CMV DNA levels serially at baseline and during the course of antiviral treatment to assess virological response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.”
— U.S. Food and Drug Administration, device classification record for product code PAB under 21 CFR 866.3180, via openFDA

Market context for product code PAB

FDA has cleared 3 devices under product code PAB, all in 2025, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PAB

Roche Molecular Systems, Inc.1 clearance
Hologic, Inc.1 clearance
Abbott Molecular, Inc.1 clearance

Recent clearances under product code PAB

K252481 — cobas CMVRoche Molecular Systems, Inc.·2025-11-03
K243485 — Alinity m CMVAbbott Molecular, Inc.·2025-07-01
K243935 — Aptima CMV Quant AssayHologic, Inc.·2025-01-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.