• 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 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 NameBIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igm
Generic Nameassay,enzyme linked immunosorbent,parvovirus b19 igm
ApplicantDIASORIN
PMA NumberP970055
Supplement NumberS011
Date Received07/06/2011
Decision Date08/03/2011
Product Code
MYM[ Registered Establishments with MYM ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing process change for preparation of the sensitivity standards, used as a reference material to establish the cut-off value for the device.
-
-