VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Premarket Approval P160016

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.

Pre-market Approval Supplement Details

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.

DeviceVERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)
Classification NameAssay, Genotyping, Hepatitis C Virus
Generic NameAssay, Genotyping, Hepatitis C Virus
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS, INC.
Date Received2016-06-06
Decision Date2017-03-14
Notice Date2017-04-21
PMAP160016
SupplementS
Product CodeOBF
Docket Number17M-1713
Advisory CommitteeMicrobiology
Expedited ReviewNo
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 NumberDateSupplement Type
P160016Original 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

Device IDPMASupp
00630414602882 P160016 000
00630414602875 P160016 000
00630414000534 P160016 000
00630414000510 P160016 000
00630414000503 P160016 000
00630414000497 P160016 000

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