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 | IMMULITE AFP ASSAY |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC. 511 BENEDICT AVE. TARRYTOWN, NY 10591 |
PMA Number | P010007 |
Supplement Number | S009 |
Date Received | 05/30/2012 |
Decision Date | 11/08/2012 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ELIMINATING THE TEST REDUNDANCY BY USING ONLY THE BIORADLYPHOCHECK IMMUNOASSAY PLUS CONTROLS IN IN-PROCESS COMPONENT TESTING, POST-FILL TESTING AND FINAL KIT COMBINATION TESTING FOR THE ASSESSMENT OF IMMULITE AFP, FREE PSA, AND PSA/3RD GENERATION PSA ASSAY PERFORMANCE. |
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