Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS & CONTROL MATERIAL
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
333 Coney Street
Walpole, MA 02032
PMA NumberP030029
Supplement NumberS005
Date Received03/03/2009
Decision Date04/09/2009
Withdrawal Date 05/24/2016
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDING ADVIA CENTAUR XP INSTRUMENT TO THE INTENDED USE OF THEAPPROVED DEVICE ADVIA CENTAUR ANTI-HBS READY PACK REAGENTS AND CALIBRATORS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR'S) AND ADVIA CENTAUR XP ANTI-HBS ASSAY AND IS INDICATED FOR:ADVIA CENTAUR ANTI-HBS READY PACK REAGENTS AND CALIBRATORTHE ADVIA CENTAUR ANTI-HBS ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMANSERUM OR PLASMA (EDTA, OR HEPARINIZED) USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OFSUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWINGHBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITHOTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATEDWITH HBV INFECTION. A REACTIVE ASSAY RESULTS WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.ADVIA CENTAUR ANTI-HBS CONTROL MATERIALFOR MONITORING THE PERFORMANCE OF THE ANTI-HBS ASSAY ON THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS.
-
-