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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.
 
DeviceIMMULITE 2000 XPI ANTI-HBC IMG
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Applicant
Siemens Healthcare Diagnostics Products, LTD
glyn rhonwy
llanberis, caernarfon LL55
PMA NumberP010053
Date Received08/31/2001
Decision Date07/26/2002
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 03M-0272
Notice Date 06/24/2003
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE IMMULITE ANTI-HBC IGM AND IMMULITE 2000 ANTI-HBC IGM. THESE DEVICES ARE INDICATED FOR: IMMULITE. ANTI-HBC IGM: IMMULITE ANTI-HBC IGM IS A SOLID-PHASE CHEMILUMINESCENT ENZYME IMMUNOASSAY DESIGNED FOR USE WITH THE IMMULITE AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE MEASUREMENT OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM AND PLASMA (EDTA, HEPARINIZED OR CITRATE). IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE OR RECENT (USUALLY WITHIN 6 MONTHS) HEPATITIS B VIRAL INFECTION. IMMULITE. 2000 ANTI-HBC IGM: IMMULITE 2000 ANTI-HBC IGM IS A SOLID-PHASE CHEMILUMINESCENT ENZYME IMMUNOASSAY DESIGNED FOR USE WITH THE IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE MEASUREMENT IF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM AND PLASMA (EDTA, HEPARINIZED OR CITRATE). IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE OR RECENT (USUALLY WITHIN 6 MONTHS) HEPATITIS B VIRAL INFECTION.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S003 S004 S006 S007 S008 S009 S010 
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