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 Class Implantable

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Option to the MAMMOMAT Inspiration FFDM system to acquire tomosynthesis images for mammography
Siemens Healthcare GmbH
11104944
In Commercial Distribution

  • 04056869001005 ()


  • Stationary mammographic x-ray system, digital
Anti-HBe2 (aHBe2) – Atellica IM – RGT 50T
Siemens Healthcare Diagnostics Inc.
10733021
In Commercial Distribution

  • 00842768022678 ()
10733021

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
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
Total Prostate Specific Antigen Flex® reagent cartridge 120 Test
Siemens Healthcare Diagnostics Inc.
10445090
In Commercial Distribution

  • 00842768016660 ()
  • 00630414601779 ()
K6451

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Heterogeneous Immunoassay Module Free Prostate Specific Antigen Flex® reagent cartridge 120 Test
Siemens Healthcare Diagnostics Inc.
10444888
In Commercial Distribution

  • 00842768013881 ()
  • 00630414601755 ()
RF452

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA)
Heterogeneous Immunoassay Module Total/Free Prostate Specific Antigen Calibrator
Siemens Healthcare Diagnostics Inc.
10445031
In Commercial Distribution

  • 00842768013751 ()
RC452

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Heterogeneous Immunoassay Module Total Prostate Specific Antigen Flex® reagent cartridge 120 Test
Siemens Healthcare Diagnostics Inc.
10444889
In Commercial Distribution

  • 00842768013874 ()
  • 00630414601762 ()
RF451

  • Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA)
Prostate Specific Antigen Calibrator
Siemens Healthcare Diagnostics Inc.
10464359
In Commercial Distribution

  • 00842768024214 ()
KC602

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
HBsAg (HBs) (1-pack) 200T Assay Kit
Siemens Healthcare Diagnostics Inc.
10309057
In Commercial Distribution

  • 00630414472867 ()
3393362

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Anti-HBs (aHBs) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10309021
Not in Commercial Distribution

  • 00630414471914 ()
1463789

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
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