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 record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameANTI-HBCM IMMULITE SUBSTRATE REAGENT
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametotal antibodies against hepatitis b core (anti-hbc) hepatitis b surface antigen (hbsag) total antibodies against hepats
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP010053
Supplement NumberS010
Date Received12/19/2011
Decision Date03/27/2012
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to remove the slip agent from the bottle used to package the immulite substrate.
-
-