• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
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 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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S003 S004 S005 S007 S008 S009 S010 S011 
-
-