|
Device | VERSANT HCV Genotype 2.0 Assay (LiPA) |
Generic Name | Assay, genotyping, hepatitis c virus |
Regulation Number | 866.3170 |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. P.O. BOX 2466 BERKELEY, CA 94702-2466 |
PMA Number | P160016 |
Supplement Number | S001 |
Date Received | 01/02/2018 |
Decision Date | 02/08/2018 |
Reclassified Date
|
12/22/2021 |
Product Code |
OBF |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |