• 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 | Inspections
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 NameBIO-RAD MONOLISA ANTI-HBC IGM EIA
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantBIO-RAD LABORATORIES, INC.
PMA NumberP060034
Supplement NumberS001
Date Received09/22/2008
Decision Date10/09/2008
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a new filling machine for use in the manufacturing of the positive and negative control vials and the calibrator vial in the kit.
-
-