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 | BIOTRON PARVOVIRUS B19 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 | S001 |
Date Received | 11/15/2002 |
Decision Date | 01/09/2003 |
Product Code |
MYL |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR ADDING A QUALITY ASSURANCE INSPECTION STEP. |
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