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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 ANTI-HBS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSiemens Healthcare Diagnostics Products, LTD
GLYN RHONWY
LLANBERIS, CAERNARFON LL55
PMA NumberP010052
Date Received08/31/2001
Decision Date07/22/2002
Product Code LOM 
Docket Number 03M-0287
Notice Date 06/24/2003
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE IMMULITE ANTI-HBS AND IMMULITE 2000 ANTI-HBS. THE DEVICES ARE INDICATED FOR: IMMULITE ANTI-HBS: FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE MEASUREMENT OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM AND PLASMA (HEPARINIZED OR EDTA). ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR 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 DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS OF SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION. IMMULITE 2000 ANTI-HBS: FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE MEASUREMENT OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM AND PLASMA (HEPARINIZED OR EDTA). ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR 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 DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS OF SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S003 S004 S005 S007 S008 S009 S010 S011 S012 S013 
S014 S015 S016 
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