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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Access Hybritech PSA; Access Hybritech PSA Calibrators (MN mfg site only); Access Hybritech PSA Sample Diluent (MN mfg site only)
Classification Name: TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER
Product Code: MTF
Device Class: 3
Registered Establishment Name: BECKMAN COULTER, INC. (IRELAND)
Registered Establishment Number: 8020879
Owner/Operator: BECKMAN COULTER, INC.
Owner/Operator Number: 2050012
Establishment Operations: Manufacturer
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