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 | IGG ENZYME IMMUNOASSAY |
Generic Name | ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG |
Applicant | DIASORIN 1951 NORTHWESTERN AVENUE STILLWATER, MN 55082-0285 |
PMA Number | P970054 |
Supplement Number | S004 |
Date Received | 05/14/2007 |
Decision Date | 06/08/2007 |
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 CHANGE IN A QUALITY CONTROL TEST FOR THE IN-PROCESS DEVICE. |
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