Approval for the versant hcv genotype 2. 0 assay (lipa) is a line probe assay, which identifies hepatitis c virus (hcv) genotypes 1 to 6 and subtypes 1a and 1b in human serum or plasma (k2edta, acd-a cpd, and cpda) samples. The versant hcv genotype 2. 0 assay (lipa) is intended to be used as an aid in the management of patients with chronic hcv infection to guide the selection of antiviral treatment.
| Device | VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA) |
| Classification Name | Assay, Genotyping, Hepatitis C Virus |
| Generic Name | Assay, Genotyping, Hepatitis C Virus |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Date Received | 2016-06-06 |
| Decision Date | 2017-03-14 |
| Notice Date | 2017-04-21 |
| PMA | P160016 |
| Supplement | S |
| Product Code | OBF |
| Docket Number | 17M-1713 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS, INC. p.o. Box 2466 berkeley, CA 94702-2466 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160016 | | Original Filing |
| S006 |
2020-07-31 |
30-day Notice |
| S005 | | |
| S004 |
2019-07-25 |
30-day Notice |
| S003 |
2019-03-08 |
30-day Notice |
| S002 | | |
| S001 |
2018-01-02 |
Real-time Process |
NIH GUDID Devices