PABClass II
Cytomegalovirus (Cmv) Dna Quantitative Assay
21 CFR 866.3180 / Microbiology
PAB is the FDA product code for Cytomegalovirus (Cmv) Dna Quantitative Assay, a class II device type, regulated under 21 CFR 866.3180. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- PAB
- Device name
- Cytomegalovirus (Cmv) Dna Quantitative Assay
- FDA 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.
- Regulation
- 21 CFR 866.3180
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 1
Clearances, product code PAB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2025 | 3 |
Applicants with the most clearances
Product code PAB| Applicant | Clearances |
|---|---|
| Abbott Molecular, Inc. | 1 |
| Hologic, Inc. | 1 |
| Roche Molecular Systems Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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