VERSANT HCV Genotype 2.0 Assay (LiPA)

FDA Premarket Approval P160016 S006

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Manufacturing process change to replace with new rna qc samples

DeviceVERSANT HCV Genotype 2.0 Assay (LiPA)
Generic NameAssay, Genotyping, Hepatitis C Virus
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS, INC.
Date Received2020-07-31
Decision Date2020-08-27
PMAP160016
SupplementS006
Product CodeOBF 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS HEALTHCARE DIAGNOSTICS, INC. p.o. Box 2466 berkeley, CA 94702-2466

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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