Access Hybritech p2PSA B03704

GUDID H628B037041

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 Index Assay (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.

Beckman Coulter, Inc.

Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Primary Device IDH628B037041
NIH Device Record Key0ad76e29-3dd4-4db9-8b9f-5578d12f6b46
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Hybritech p2PSA
Version Model NumberB03704
Catalog NumberB03704
Company DUNS008254708
Company NameBeckman Coulter, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH628B037041 [Primary]

FDA Product Code

OYAP2psa

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-06
Device Publish Date2014-09-16

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