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.
 
DeviceVITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantOrtho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER, NY 14626-5101
PMA NumberP000014
Supplement NumberS009
Date Received09/15/2004
Decision Date09/27/2004
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE FROM THE QUALITATIVE DETECTION OF TOTAL ANTI-HBS IN HUMAN SERUM TO A QUANTITATIVE DETECTION OF TOTAL ANTI-HBS IN HUMAN SERUM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATORS. THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK IS INDICATED FOR: "THE QUANTITATIVE IN VITRO DETERMINATION OF TOTAL ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM. 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 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATORS IS INDICATED FOR: "FOR USE IN THE CALIBRATION OF THE VITROS ICI/ECIQ IMMUNODIAGNOSTIC SYSTEM FOR THE QUANTITATIVE IN VITRO DETERMINATION OF TOTAL ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM USING THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK."
-
-