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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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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
Folate Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445138
In Commercial Distribution

  • 00842768016653 ()
  • 00630414005072 ()
K6444

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
Beta Human Chorionic Gonadotropin Calibrator, 2x4x1mL / 2x2mL / 2x1.5mL
Siemens Healthcare Diagnostics Inc.
10445192
In Commercial Distribution

  • 00842768016516 ()
KC632

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, calibrator
Myoglobin Calibrator, 2x1.5mL / 2x2.5mL / 2x2.0mL
Siemens Healthcare Diagnostics Inc.
10445191
In Commercial Distribution

  • 00842768016509 ()
KC624

  • Myoglobin IVD, calibrator
Ecstasy Calibrator, 3x2x2.3mL
Siemens Healthcare Diagnostics Inc.
10445188
In Commercial Distribution

  • 00842768016486 ()
KC520

  • Amphetamine/methamphetamine group IVD, calibrator
Drugs of Abuse Negative Control, 6x2.5mL
Siemens Healthcare Diagnostics Inc.
10445199
In Commercial Distribution

  • 00842768016479 ()
  • 00630414005294 ()
KC516

  • Multiple drugs of abuse IVD, control
Drugs of Abuse Positive Control, 6x2.5mL
Siemens Healthcare Diagnostics Inc.
10445198
In Commercial Distribution

  • 00842768016462 ()
  • 00630414005287 ()
KC515

  • Multiple drugs of abuse IVD, control
Drugs of Abuse Calibrator, 4x2.5mL / 2x2.6mL
Siemens Healthcare Diagnostics Inc.
10445187
In Commercial Distribution

  • 00842768016455 ()
KC510

  • Multiple drugs of abuse IVD, calibrator
Cyclosporine Extended Range Calibrator, 3x2mL / 3x1.5ml
Siemens Healthcare Diagnostics Inc.
10445186
Not in Commercial Distribution

  • 00842768016448 ()
KC440

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Urinary/Cerebrospinal Fluid Protein Calibrator, 3x1.5mL
Siemens Healthcare Diagnostics Inc.
10445178
In Commercial Distribution

  • 00842768016431 ()
KC260

  • Total protein IVD, calibrator
Sample Probe Cleaner, 2x2.4 L
Siemens Healthcare Diagnostics Inc.
10445209
In Commercial Distribution

  • 00842768016356 ()
  • 00630414005386 ()
KS807

  • Wash/cleaning solution IVD, automated/semi-automated system
Reagent Probe Cleaner, 2x2.4 L
Siemens Healthcare Diagnostics Inc.
10445208
In Commercial Distribution

  • 00842768016349 ()
  • 00630414005379 ()
KS806

  • Wash/cleaning solution IVD, automated/semi-automated system
Cuvette wash solution, 2 x 2.4 L
Siemens Healthcare Diagnostics Inc.
10445207
In Commercial Distribution

  • 00842768016332 ()
  • 00630414005362 ()
KS805

  • Wash/cleaning solution IVD, automated/semi-automated system
Dimension Vista® System Diluent, 2x1.5 L
Siemens Healthcare Diagnostics Inc.
10445206
In Commercial Distribution

  • 00842768016325 ()
  • 00630414005355 ()
KS804

  • Buffered sample diluent IVD
Empty Vials Kit, 357 Vials, 375 Caps, 3 X 550 Labels
Siemens Healthcare Diagnostics Inc.
10445213
In Commercial Distribution

  • 00842768016295 ()
KS865

  • Assay container IVD, single-use
LOCI® Reaction Vessel, 1000 Pieces
Siemens Healthcare Diagnostics Inc.
10445212
In Commercial Distribution

  • 00842768016288 ()
  • 00630414005416 ()
KS855

  • Assay container IVD, single-use
Cuvettes, 20x240 (4800)
Siemens Healthcare Diagnostics Inc.
10445211
In Commercial Distribution

  • 00842768016271 ()
  • 00630414005409 ()
KS850

  • Laboratory analyser cuvette IVD, single-use
Aliquot Plates, 30x12 (360)
Siemens Healthcare Diagnostics Inc.
10445210
In Commercial Distribution

  • 00842768016264 ()
  • 00630414005393 ()
KS840

  • General specimen container IVD, no additive/medium
V-LYTE® Dilution Check, 6x2mL
Siemens Healthcare Diagnostics Inc.
10445203
In Commercial Distribution

  • 00842768016257 ()
  • 00630414005331 ()
K840

  • Multiple electrolyte IVD, reagent
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