| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA) |
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| Generic Name | Assay, genotyping, hepatitis c virus |
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| Regulation Number | 866.3170 |
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| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC.
P.O. BOX 2466
BERKELEY, CA 94702-2466 |
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| PMA Number | P160016 |
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| Date Received | 06/06/2016 |
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| Decision Date | 03/14/2017 |
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|
Reclassified Date
|
12/22/2021 |
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| Product Code |
OBF |
| Docket Number | 17M-1713 |
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| Notice Date | 04/21/2017 |
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| Advisory Committee |
Microbiology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S003 S004 S005 S006 |
|
|
