Cytomegalovirus (cmv) Dna Quantitative Assay
Device Code: 3622
Product Code(s):
PAB Definition: Cytomegalovirus (CMV) DNA Quantitative Assay Is An In Vitro Nucleic Acid Assay For The Quantitative Measurement Of CMV DNA In Human Plasma Or Whole Blood. The Assay Can Be Used To Measure CMV DNA Levels Serially At Baseline And During The Course Of A
Device Classification Information
| Device Type ID | 3622 |
| Device Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Physical State | IVD |
| Technical Method | In Vitro Nucleic Acid Based Assay Using Real-time PCR For The Quantitative Measurement Of CMV DNA |
| Target Area | Not Applicable |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PAB |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3622 |
| Device | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Product Code | PAB |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems |
|---|
False Positive Result | 3 |
| Total Device Problems | 3 |
TPLC Last Update: 2019-04-02 20:33:20