Address:250 S Kraemer Blvd,BREA,CA,92821,US
Device Description : The Access Hybritech PSA Sample Diluent is intended for use with the Access Hybr The Access Hybritech PSA Sample Diluent is intended for use with the Access Hybritech PSA assay to dilute patient samples containing total prostate specific antigen (PSA) concentrations greater than the S5 calibrator.
Device Class : 3
Duns Number: 008254708
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Access Hybritech PSA QC are tri-level controls intended for monitoring syste The Access Hybritech PSA QC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of total Prostate Specific Antigen (PSA) using the Access Immunoassay Systems.
Device Class : 1
Duns Number: 008254708
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (free PSA) in human serum using the Access Immunoassay Systems. Access Hybritech free PSA is intended to be used with Hybritech (total) PSA to calculate the ratio of free PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA as measured by the Hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, when used in conjunction with Hybritech (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/mL with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
Device Class : 3
Duns Number: 008254708
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Access Hybritech free PSA Calibrators are intended to calibrate the Access H The Access Hybritech free PSA Calibrators are intended to calibrate the Access Hybritech free PSA assay for the quantitative determination of free PSA levels in human serum using the Access Immunoassay Systems.
Device Class : 3
Duns Number: 008254708
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Access Hybritech free PSA QC are bi-level controls intended for monitoring s The Access Hybritech free PSA QC are bi-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of free Prostate Specific Antigen (free PSA) using the Access Immunoassay Systems.
Device Class : 1
Duns Number: 008254708
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Access Hybritech p2PSA QC are tri-level controls intended for monitoring sys The Access Hybritech p2PSA QC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of [-2]proPSA isoform of Prostate Specific Antigen (PSA) using the Access Immunoassay Systems.
Device Class : 1
Duns Number: 008254708
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Access Hybritech p2PSA assay is a paramagnetic particle, chemiluminescent im The Access Hybritech p2PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of [-2]proPSA antigen, an isoform of free PSA, in human serum using the Access Immunoassay Systems. Access Hybritech p2PSA is intended to be used in combination with Access Hybritech (total) PSA and Access Hybritech free PSA to calculate the Beckman Coulter Prostate Health Index (phi), an In Vitro Diagnostic Multivariate IndexAssay (IVDMIA). Beckman Coulter phi as calculated using the Access Hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, for prostate cancer detection in men aged 50 years and older with total PSA ≥ 4.0 to ≤ 10.0 ng/mL, and with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
Device Class : 3
Duns Number: 008254708
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Access Hybritech p2PSA Calibrators are intended to calibrate the Access Hybr The Access Hybritech p2PSA Calibrators are intended to calibrate the Access Hybritech p2PSA assay as an aid in distinguishing prostate cancer from benign prostatic conditions using human serum on the Access Immunoassay Systems.
Device Class : 3
Duns Number: 008254708
Premarket Exempt : No
Prescription Use : Yes