|
Device | PARVOVIRUS B19 IgG ENZYME IMMUNOASSAY (V519GUS) |
Generic Name | ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG |
Applicant | DIASORIN 1951 NORTHWESTERN AVENUE STILLWATER, MN 55082-0285 |
PMA Number | P970054 |
Supplement Number | S011 |
Date Received | 02/02/2016 |
Decision Date | 03/03/2016 |
Product Code |
MYL |
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 Modification of the conjugate optimization process. |