• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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.
 
Trade NameIMMULITE 2000 XPI ANTI-HBS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP010052
Date Received08/31/2001
Decision Date07/22/2002
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 03M-0287
Notice Date 06/24/2003
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: S001 S003 S004 S005 S007 S008 S009 S010 S011 
-
-