FDA.reportPublic FDA data

Access Hybritech PSA

Primary DI
H628372001
Brand
Access Hybritech PSA
Company
Beckman Coulter, Inc.
Model
37200
Catalog number
37200
Device description
The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.
Published
2014-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MTFTotal,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTFTotal, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate CancerUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H628372001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen, using a chemiluminescent immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590701673Access Hybritech PSABeckman Coulter, Inc.MTF2025-05-30
07613336217665Elecsys Total PSARoche Diagnostics GmbHMTF2024-10-24
00380740130411AlinityAbbott Ireland DiagnosticsMTF2020-11-18
00380740130428AlinityAbbott Ireland DiagnosticsMTF2020-11-18
00380740158316AlinityAbbott Ireland DiagnosticsMTF2020-11-18
00380740158323AlinityAbbott Ireland DiagnosticsMTF2020-11-18
07613336165980Elecsys total PSARoche Diagnostics GmbHMTF2020-08-24
07613336165997Elecsys total PSARoche Diagnostics GmbHMTF2020-08-24
07613336166000Elecsys total PSARoche Diagnostics GmbHMTF2020-08-24
07613336167496total PSA CalSet IIRoche Diagnostics GmbHMTF2020-08-24
04015630939824Elecsys total PSARoche Diagnostics GmbHMTF2018-07-16
00630414598444Atellica IM Calibrator QSiemens Healthcare Diagnostics Inc.MTF2017-12-27
00630414598451Atellica IM Calibrator QSiemens Healthcare Diagnostics Inc.MTF2017-12-22
07613336154366Elecsys tPSARoche Diagnostics GmbHMTF2017-09-29
07613336154373Elecsys tPSARoche Diagnostics GmbHMTF2017-09-29
07613336154380total PSA Calset IIRoche Diagnostics GmbHMTF2017-09-29
04015630920754Elecsys Total PSA CalSet IIRoche Diagnostics GmbHMTF2014-12-18
00380740008963ARCHITECTAbbott Ireland DiagnosticsMTF2014-11-18
00380740008970ARCHITECTAbbott Ireland DiagnosticsMTF2014-11-18
00380740008987ARCHITECTAbbott Ireland DiagnosticsMTF2014-11-18
00380740008994ARCHITECTAbbott Ireland DiagnosticsMTF2014-11-18
00842768013874Dimension® clinical chemistry system TPSA Flex® reagent cartridgeSiemens Healthcare Diagnostics Inc.MTF2014-09-24
00842768016660Dimension Vista® System TPSA Flex® Reagent CartridgeSiemens Healthcare Diagnostics Inc.MTF2014-09-24
00630414202921ADVIA Centaur® Systems, ACS:180® Systems Calibrator QSiemens Healthcare Diagnostics Inc.MTF2014-09-24
00630414202938ADVIA Centaur® Systems. ACS:180® Systems Calibrator QSiemens Healthcare Diagnostics Inc.MTF2014-09-24
00630414954196IMMULITE®/IMMULITE®1000 Systems PSA PSA Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24
00630414982205IMMULITE®/IMMULITE®1000 Systems PTS PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24
00630414982212IMMULITE® 2000 Systems PTS PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24
00630414982229IMMULITE® 2000 Systems PTS PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24
00630414982267IMMULITE®/IMMULITE®1000 Systems 3PS Third Generation PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24