Approval for a modification to the assay procedure to allow the versant kpcr molecular system sample preparation module to automatically set up the pcr plate following the rna extraction step.
| 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 | 2018-01-02 |
| Decision Date | 2018-02-08 |
| PMA | P160016 |
| Supplement | S001 |
| Product Code | OBF |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS, INC. p.o. Box 2466 berkeley, CA 94702-2466 |
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