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

• Device: VERSANT HCV Genotype 2.0 Assay (LiPA)
• Generic Name: Assay, Genotyping, Hepatitis C Virus
• Applicant: SIEMENS HEALTHCARE DIAGNOSTICS, INC.
• Date Received: 2020-07-31
• Decision Date: 2020-08-27
• PMA: P160016
• Supplement: S006
• Product Code: OBF
• Advisory Committee: Microbiology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: SIEMENS HEALTHCARE DIAGNOSTICS, INC. p.o. Box 2466 berkeley, CA 94702-2466

Supplemental Filings

Supplement Number	Date	Supplement Type
P160016		Original 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 ID	PMA	Supp
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