Access Hybritech free PSA 37210

GUDID H628372101

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.

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 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 Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Primary Device IDH628372101
NIH Device Record Key90fa28b2-ce72-4600-b005-4e7a57e32a8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Hybritech free PSA
Version Model Number37210
Catalog Number37210
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
HIBCCH628372101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MTGTest,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

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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