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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 HBSAG
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
PMA NumberP010050
Date Received08/31/2001
Decision Date07/26/2002
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 03M-0262
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 hbsag, immulite 2000 hbsag and immulite hbsag confirmatory kit. These devices are indicated for: immulite hbsag: immulite hbsag is a solid-phased chemiluminescent enzyme immunoassay designed for in vitro use with the immulite automated immunoassay analyzer for the qualitative detection of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, heparinized, citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis b virus infections in conjunction with other serological and clinical information. In addition, this assay may be used to screen for hepatitis b infection in pregnant women to identify neonates who are at high risk of acquiring hbv during the perinatal period. Immulite. 2000 hbsag: immulite 2000 hbsag is a solid-phase chemiluminescent enzyme immunoassay designed for in vitro use with the immulite 2000 automated immunoassay analyzer for the qualitative detection of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, heparinized, citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis b virus infections in conjunction with other serological and clinical information. In addition, this assay may be used to screen for hepatitis b infection in pregnant women to identify neonates who are at high risk of acquiring hbv during the perinatal period. Immulite hbsag confirmatory kit: immulite hbsag confirmatory is intended for in vitro diagnostic use in conjunction with the immulite hbsag or the immulite 2000 hbsag assays for the confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, heparinized, citrate) that were repeatedly positive when tested by immulite or immulite 2000 hbsag.
Approval Order Approval Order
Supplements: S001 S003 S005 S006 S007 S008 S010 S011 S012 
S013 S014 S015 
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