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. |
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Device | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P980041 |
Supplement Number | S022 |
Date Received | 01/23/2013 |
Decision Date | 03/25/2013 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR 1) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THEREACTION VESSEL CONTAINER MATERIAL THAT IS USED AS THE CONTAINER FOR THE REACTION IN THE DETERMINATION OF RESULTS FOR ACCESS AFP REAGENTS, ACCESS HYBRITECH PSA REAGENTS, ACCESS HYBRITECH FREE PSA REAGENTS AND ACCESS HYBRITECH P2PSA REAGENTS; 2) THE CHANGE INPOLYPROPYLENE RESIN USED FOR THE REAGENT PACK CONTAINER FOR ACCESS HYBRITECH P2PSA REAGENTS AND 3) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THE BOTTLE CAP FOR ACCESS AFP SAMPLE DILUENT AND ACCESS HYBRITECH PSA SAMPLE DILUENT AND ACCESS SUBSTRATE FOR ACCESS AFP, ACCESS HYBRITECH PSA, ACCESS HYBRITECH FREE PSA AND ACCESS HYBRITECH P2PSA. |
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