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 Class Implantable

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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
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