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Siemens Healthcare Diagnostics, Inc. Registered Devices

Listing registered devices, PMA filings, and compliance records for Siemens Healthcare Diagnostics, Inc..

pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
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pma Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) ID: P100039
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pma Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) ID: P100039
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pma Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) ID: P100039
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pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P240021
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pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
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pma Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus ID: P020022
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P010007
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pma PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS ID: P930027
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pma Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) ID: P100039
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P930036
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pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P930036
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P930036
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pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
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pma Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) ID: P100039
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P930036
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pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
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pma Qualitative and Quantitative Hepatitis B Virus Antibody assays ID: P200017
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pma Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) ID: P100039
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P010007
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P010007
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pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
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pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P010007
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P930036
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pma Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus ID: P020022
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P930036
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pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
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pma Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) ID: P100039
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pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
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pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P010007
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P930036
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pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
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pma PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS ID: P930027
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P930036
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P010007
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pma PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS ID: P930027
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P010007
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pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P930036
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P930036
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pma Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions ID: P250026
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pma Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) ID: P200017
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pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
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pma PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS ID: P930027
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pma IMMULITE PSA, IMMULITE 2000 PSA, IMMULITE Third Generation PSA, IMMULITE 2000 Third Generation PSA ID: P930027
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pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P930036
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pma Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) ID: P200017
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P930036
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P010007
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pma Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) ID: P100039
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P010007
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pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P010007
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P010007
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pma Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) ID: P100039
View Details →
pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P010007
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P930036
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pma Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) ID: P100039
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pma Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) ID: P210019
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pma Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) ID: P100039
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pma Qualitative and Quantitative Hepatitis B Virus Antibody assays ID: P100039
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P930036
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P010007
View Details →
pma PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS ID: P930027
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pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
View Details →
pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
View Details →
pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
View Details →
pma Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) ID: P210019
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pma Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) ID: P210019
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P010007
View Details →
pma Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus ID: P020022
View Details →
pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
View Details →
pma Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer ID: P930027
View Details →
pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P930036
View Details →
pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P010007
View Details →
pma Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus ID: P020022
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pma KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS ID: P010007
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enforcement Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. ID: Z-2703-2026
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enforcement Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay ID: Z-2398-2026
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enforcement Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. ID: Z-1980-2026
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enforcement Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536; ID: Z-1657-2026
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enforcement Atellica CH Urine Albumin (UAlb). Material Number: 11537225 ID: Z-1484-2026
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enforcement Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543. ID: Z-2542-2025
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enforcement ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control) ID: Z-2089-2025
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enforcement ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) ID: Z-2088-2025
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enforcement ADVIA 120/2120/2120i SETpoint Calibrator ID: Z-2086-2025
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enforcement Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300; ID: Z-2027-2025
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enforcement ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) ID: Z-2087-2025
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enforcement epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care. ID: Z-0738-2025
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enforcement epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care. ID: Z-0737-2025
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enforcement epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care. ID: Z-0741-2025
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enforcement Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223. ID: Z-1551-2025
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enforcement epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care. ID: Z-0739-2025
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enforcement Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158; ID: Z-0767-2025
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enforcement epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care. ID: Z-0735-2025
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enforcement epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care. ID: Z-0734-2025
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