VERSANT HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Premarket Approval P160016 S003

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

Relocation of reagent manufacture from one building to another within the same establishment

DeviceVERSANT HCV Genotype 2.0 Assay (LiPA)
Classification NameAssay, Genotyping, Hepatitis C Virus
Generic NameAssay, Genotyping, Hepatitis C Virus
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS, INC.
Date Received2019-03-08
Decision Date2019-04-05
PMAP160016
SupplementS003
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
05414470816590 P160016 000
05414470816613 P160016 000
05414470816620 P160016 000
05414470816637 P160016 000
00630414000497 P160016 000
00630414000503 P160016 000
00630414000510 P160016 000
00630414000534 P160016 000
00630414602875 P160016 000
05414470156870 P160016 000

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