|
Device | Access Hybritech Free PSA Reagents on the Access Immunoassay Systems |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P970038 |
Supplement Number | S045 |
Date Received | 04/19/2021 |
Decision Date | 12/16/2022 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a modification to the UniCel DxI Immunoassay systems sample probe and reagent probe wash nozzle design using injection molding to reduce production cost. |