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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: ADVIA Centaur Calibrator Y (CAL Y); ADVIA Centaur Complexed Prostate-specific Antigen (cPSA); ADVIA Centaur Complexed Prostate-Specific Antigen Master Curve Material (cPSA MCM); ADVIA Centaur Complexed Prostate-specific Antigen Pretreatment Reagent (cPSA Pre); ADVIA Centaur Complexed Prostate-specific Antigen Quality Control (cPSA QC); Atellica IM Calibrator Y (CAL Y); Atellica IM Complexed Prostate-specific Antigen (cPSA); Atellica IM Complexed Prostate-specific Antigen Pretreatment Reagent (cPSA Pre); Atellica IM Complexed Prostate-specific Antigen Quality Control (cPSA QC)
Classification Name: ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
Product Code: NAF
Device Class: 3
Registered Establishment Name: Siemens Healthcare Diagnostics Inc.
Registered Establishment Number: 1219913
Premarket Submission Number: P990055
Owner/Operator: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner/Operator Number: 9096044
Establishment Operations: Manufacturer
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