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 NameDIASORIN ETI-AB-HAVK PLUS ASSAY
Classification Namehepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantDIASORIN, INC.
PMA NumberP890019
Supplement NumberS009
Date Received01/30/2004
Decision Date02/20/2004
Product Code
LOL[ Registered Establishments with LOL ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes to the package insert: the supplement contains a revision in the assay package insert that states "all lots of incubation buffer are interchangeable between eti-ebk plus, eti-ab-ebk plus, eti-ab-havk plus. ".
-
-