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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameIMMULITE 2000 XPI ANTI-HBC
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
PMA NumberP010051
Date Received08/31/2001
Decision Date07/24/2002
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 
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