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

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