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) | 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAlinity i Anti-HBc IgM Reagent Kit, Alinity i Anti-HBc IgM Calibrators, Alinity i Anti-HBc IgM Controls
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
AP5N-2, DEPT. 09VB
ABBOTT PARK, IL 60064-3500
PMA NumberP060035
Supplement NumberS026
Date Received06/01/2018
Decision Date06/20/2019
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for migration of the ARCHITECT CORE-M Reagent Kit, ARCHITECT CORE-M Calibrators, ARCHITECT CORE-M Controls onto the Alinity i Analyzer. The manufacture of the Alinity i analyzer would be done at a new contract manufacturer, Sanmina, Singapore.
-
-