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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/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.
 
DeviceIMMULITE 2000 XPI HBSAG
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSiemens Healthcare Diagnostics Products, LTD
GLYN RHONWY
LLANBERIS, CAERNARFON LL55
PMA NumberP010050
Date Received08/31/2001
Decision Date07/26/2002
Product Code LOM 
Docket Number 03M-0262
Notice Date 06/24/2003
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S013 S014  S001 S003 S005 S006 S007 S008 S010 S011 S012 
S015 S016 S017 S018 S019 S020 S021 
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