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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Access Hybritech free PSA; Access Hybritech Free PSA Calibrators (MN mfg site only)
Classification Name: TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS
Product Code: MTG
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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