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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: ARCHITECT Total PSA Calibrators; ARCHITECT Total PSA Controls; ARCHITECT Total PSA Reagent Kit
Classification Name: TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER
Product Code: MTF
Device Class: 3
Registered Establishment Name: ABBOTT IRELAND
Registered Establishment Number: 3008344661
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Manufacturer
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