• 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 HBSAG
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 NumberP010050
Date Received08/31/2001
Decision Date07/26/2002
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 03M-0262
Notice Date 06/24/2003
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the immulite hbsag, immulite 2000 hbsag and immulite hbsag confirmatory kit. These devices are indicated for: immulite hbsag: immulite hbsag is a solid-phased chemiluminescent enzyme immunoassay designed for in vitro use with the immulite automated immunoassay analyzer for the qualitative detection of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, heparinized, citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis b virus infections in conjunction with other serological and clinical information. In addition, this assay may be used to screen for hepatitis b infection in pregnant women to identify neonates who are at high risk of acquiring hbv during the perinatal period. Immulite. 2000 hbsag: immulite 2000 hbsag is a solid-phase chemiluminescent enzyme immunoassay designed for in vitro use with the immulite 2000 automated immunoassay analyzer for the qualitative detection of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, heparinized, citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis b virus infections in conjunction with other serological and clinical information. In addition, this assay may be used to screen for hepatitis b infection in pregnant women to identify neonates who are at high risk of acquiring hbv during the perinatal period. Immulite hbsag confirmatory kit: immulite hbsag confirmatory is intended for in vitro diagnostic use in conjunction with the immulite hbsag or the immulite 2000 hbsag assays for the confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, heparinized, citrate) that were repeatedly positive when tested by immulite or immulite 2000 hbsag.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S003 S005 S006 S007 S008 S010 S011 S012 
S013 S014 S015 S016 
-
-