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) | Registration & Listing | Adverse Events | Recalls | PMA | 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.
 
Trade NameIMMULITE 2000 XPI ANTI-HBC IMG
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP010053
Date Received08/31/2001
Decision Date07/26/2002
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 03M-0272
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-hbc igm and immulite 2000 anti-hbc igm. These devices are indicated for: immulite. Anti-hbc igm: immulite anti-hbc igm is a solid-phase chemiluminescent enzyme immunoassay designed for use with the immulite automated immunoassay analyzer for the qualitative measurement of igm antibody to hepatitis b core antigen (anti-hbc igm) in human serum and plasma (edta, heparinized or citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of acute or recent (usually within 6 months) hepatitis b viral infection. Immulite. 2000 anti-hbc igm: immulite 2000 anti-hbc igm is a solid-phase chemiluminescent enzyme immunoassay designed for use with the immulite 2000 automated immunoassay analyzer for the qualitative measurement if igm antibody to hepatitis b core antigen (anti-hbc igm) in human serum and plasma (edta, heparinized or citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of acute or recent (usually within 6 months) hepatitis b viral infection.
Approval Order Approval Order
Supplements: S001 S003 S004 S006 S007 S008 
S009 S010 
-
-