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.
 
DeviceABBOTT AXSYM ANTI-HCV
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
Regulation Number866.3169
ApplicantAbbott Laboratories
100 Abbott Park Rd.
Ap5n-2, Dept. 09vb
Abbott Park, IL 60064
PMA NumberP970027
Supplement NumberS006
Date Received02/11/2008
Decision Date02/22/2008
Withdrawal Date11/08/2013
Product Code MZO 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING MODIFICATIONS THAT CORRECT THE ERROR IN THE AXSYM ANTI-HCV PACKAGE INSERT (LIST NUMBER 5C36) UNDER REATENTS SECTION. THE MINIMUM CONCENTRATION OF ?% SOLIDS? FOR THE RECOMBINANT HCV ANTIGEN COATED MICROPARTICLES OF THE AXSYM ANTI-HCV REAGENT PACK IS BEING CHANGED FROM ?0.05%? TO ?0.04%? TO ALIGN WITH CURRENT MANUFACTURING PROCESS.
-
-