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FDA PRODUCT CODE · CLASS II

PAB — Cytomegalovirus (Cmv) Dna Quantitative Assay

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 866.3180
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
7
510(K)/PMA CLEARANCES
pma: 4 · 510k: 3
0
RECALL ENTRIES

Recent clearances

K252481Roche Molecular Systems, Inc. · 510k2025-11-03
K243485Abbott Molecular, Inc. · 510k2025-07-01
K243935Hologic, Inc. · 510k2025-01-17
P210029Hologic, Inc. · pma2024-10-23
P160041Roche Molecular Systems, Inc. · pma2024-10-10
P110037Roche Molecular Systems, Inc. · pma2024-10-04
P210022Abbott Molecular, Inc. · pma2024-09-13

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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