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Device | BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY |
Generic Name | ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM |
Applicant | DIASORIN 1951 NORTHWESTERN AVENUE STILLWATER, MN 55082-0285 |
PMA Number | P970055 |
Supplement Number | S011 |
Date Received | 07/06/2011 |
Decision Date | 08/03/2011 |
Product Code |
MYM |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MANUFACTURING PROCESS CHANGE FOR PREPARATION OF THE SENSITIVITY STANDARDS, USED AS A REFERENCE MATERIAL TO ESTABLISH THE CUT-OFF VALUE FOR THE DEVICE. |