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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Elecsys free PSA - 07613336166628

No Description
Roche Diagnostics GmbH
08828610190
In Commercial Distribution

  • 07613336166628 ()
08828610190

  • Free (unbound) prostate specific antigen (fPSA) IVD, control

free PSA CalCheck - 07613336154403

No Description
Roche Diagnostics GmbH
03500373190
Not in Commercial Distribution

03500373190

  • Free (unbound) prostate specific antigen (fPSA) IVD, control

Elecsys free PSA - 07613336154397

fPSA reagent
Roche Diagnostics GmbH
03289788160
In Commercial Distribution

03289788160

  • Free (unbound) prostate specific antigen (fPSA) IVD, control

Dimension Vista® System FPSA Flex® Reagent Cartridge - 00842768016677

Free Prostate Specific Antigen Flex® reagent cartridge 80 Test
Siemens Healthcare Diagnostics Inc.
10445091
In Commercial Distribution

  • 00842768016677 ()
  • 00630414601786 ()
K6452

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

Alinity - 00380740158347

Alinity i Free PSA Reagent Kit 1000 Tests
Abbott Ireland Diagnostics
07P9331
In Commercial Distribution

  • 00380740158347 ()
07P9331

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

Alinity - 00380740158330

Alinity i Free PSA Reagent Kit 200 Tests
Abbott Ireland Diagnostics
07P9321
In Commercial Distribution

  • 00380740158330 ()
07P9321

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740009021

ARCHITECT Free PSA Reagent Kit
Abbott Ireland Diagnostics
6C07-27
In Commercial Distribution

  • 00380740009021 ()
06C0727

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740009014

ARCHITECT Free PSA Controls
Abbott Ireland Diagnostics
6C07-10
In Commercial Distribution

  • 00380740009014 ()
06C0710

  • Free (unbound) prostate specific antigen (fPSA) IVD, control

Alinity - 00380740130312

Alinity i Free PSA Controls
Abbott Ireland Diagnostics
07P9310
In Commercial Distribution

  • 00380740130312 ()
07P9310

  • Free (unbound) prostate specific antigen (fPSA) IVD, control

Elecsys Free PSA Immunoassay - 04015630919321

No Description
Roche Diagnostics GmbH
03289788160
Not in Commercial Distribution

  • 04015630919321 ()
03289788160

  • Free (unbound) prostate specific antigen (fPSA) IVD, control
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