MONOLISA ANTI-HBS EIA

FDA Premarket Approval P050048

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 monolisa anti-hbs eia and the monolisa anti-hbs calibrator kit. The devices are indicated for: the monolisa anti-hbs eia is a qualitative and quantitative enzyme immunoassay for the detection of antibody to hepatitis b surface antigen in human serum and edta or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection in individuals prior to or following hbv vaccination or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The monolisa anti-hbs calibrator kit is intended for quantitative determination of anti-hbs in human serum and edta or citrated plasma. The monolisa anti-hbs calibrator kit is to be used only with the monolisa anti-hbs eia.

• Device: MONOLISA ANTI-HBS EIA
• Generic Name: Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
• Applicant: BIO-RAD LABORATORIES
• Date Received: 2005-12-05
• Decision Date: 2006-08-25
• Notice Date: 2007-04-19
• PMA: P050048
• Supplement: S
• Product Code: LOM
• Docket Number: 07M-0151
• Advisory Committee: Microbiology
• Expedited Review: No
• Combination Product: No
• Applicant Address: BIO-RAD LABORATORIES 6565 185th Ave, Ne redmond, WA 98052
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P050048		Original Filing
S009	2013-11-13	30-day Notice
S008	2012-10-19	30-day Notice
S007	2012-02-22	135 Review Track For 30-day Notice
S006	2010-06-18	135 Review Track For 30-day Notice
S005	2010-06-17	Normal 180 Day Track No User Fee
S004	2009-09-28	Normal 180 Day Track
S003
S002	2008-09-30	Real-time Process
S001	2008-07-01	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00847865002110	P050048	000
00847865002103	P050048	000
00847865002097	P050048	000
00847865002080	P050048	000
00847865002073	P050048	000
00847865002066	P050048	000
00847865002059	P050048	000
00847865002042	P050048	000