Cytomegalovirus (Cmv) Dna Quantitative Assay
The Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma, used to measure CMV viral load serially at baseline and during antiviral treatment to assess virological response; results must be interpreted within the context of all relevant clinical and laboratory findings. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is PAB, with regulation number 866.3180 under the Microbiology medical specialty.
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Basic Information
- Product Code
- PAB
- Device Class
- FDA class 2
- Regulation Number
- 866.3180
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252481 | cobas CMV | Nov 03, 2025 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K243485 | Alinity m CMV | Jul 01, 2025 | Substantially Equivalent | Abbott Molecular, Inc. |
| K243935 | Aptima CMV Quant Assay | Jan 17, 2025 | Substantially Equivalent | Hologic, Inc. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.