Premarket Approval (PMA)

Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.

• Trade Name: IMMULITE 2000 XPI ANTI-HBC
• Classification Name: test, hepatitis b (b core, be antigen, be antibody, b core igm)
• Applicant: SIEMENS HEALTHCARE DIAGNOSTICS
• PMA Number: P010051
• Date Received: 08/31/2001
• Decision Date: 07/24/2002
• Product Code: LOM [ Registered Establishments with LOM ]
• Docket Number: 03M-0271
• Notice Date: 06/24/2003
• Advisory Committee: Microbiology
• Expedited Review Granted?: No
• Combination Product: No
• Information About: Labeling, Approval Order, Summary of Safety and Effectiveness

Approval Order Statement 
Approval for the immulite anti-hbc and immulite 2000 anti-hbc. These devices are indicated for: immulite. Anti-hbc: immulite anti-hbc is a solid -phase chemiluminescent enzyme immunoassay designed for use on the immulite automated immunoassay analyzer for the qualitative detection of total antibodies against hepatitis b core antigen (anti-hbc) in human serum or plasma (edta, heparinized, citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of ongoing or previous hepatitis b virus infection. Immulite. 2000 anti-hbc: immulite 2000 anti-hbc is a solid-phase chemiluminescent enzyme immunoassay designed for use on the immulite 2000 automated immunoassay analyzer for the qualitative detection of total antibodies against hepatitis b core antigen (anti-hbc) in human serum or plasma (edta, heparinized, citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of ongoing or previous hepatitis b virus infection.

Approval Order

Approval Order

• Supplements: S001 S003 S004 S005 S007 S008 ; S009 S010 S011