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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Drugs of Abuse Negative Control, 6x5mL
Siemens Healthcare Diagnostics Inc.
10445032
In Commercial Distribution

  • 00842768005145 ()
  • 00630414004624 ()
DC44A

  • Multiple drugs of abuse IVD, control
Drugs of Abuse Positive Control, 6x5mL
Siemens Healthcare Diagnostics Inc.
10445033
In Commercial Distribution

  • 00842768005138 ()
  • 00630414004631 ()
DC43A

  • Multiple drugs of abuse IVD, control
Revised C-Reactive Protein Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10445026
In Commercial Distribution

  • 00842768005107 ()
  • 00630414017204 ()
DC34

  • C-reactive protein (CRP) IVD, calibrator
C-Reactive Protein Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10444988
Not in Commercial Distribution

  • 00842768005084 ()
  • 00630414016979 ()
DC30

  • C-reactive protein (CRP) IVD, calibrator
Pseudocholinesterase Verifier, 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10444987
In Commercial Distribution

  • 00842768005077 ()
  • 00630414016962 ()
DC28

  • Pseudocholinesterase IVD, control
Stratus® CS STAT Fluorometric Analyzer Rotor is an in vitro diagnostics device which is intended to be used on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10445088
In Commercial Distribution

  • 00842768004674 ()
  • 00630414009988 ()
CROTOR

  • Centrifuge rotor, fixed angle
The Stratus® CS Acute Care(TM) Myoglobin Calibrator (MYO CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care(TM) MYO method.
Siemens Healthcare Diagnostics Inc.
10445080
In Commercial Distribution

  • 00842768004612 ()
  • 00630414009933 ()
CMYO-C

  • Myoglobin IVD, kit, fluorescent immunoassay
Stratus® CS STAT Fluorometric Analyzer Waste Container holds used rotors, tips, cups and paks and is an in vitro diagnostic product intended to be used on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10445078
In Commercial Distribution

  • 00842768004599 ()
  • 00630414009919 ()
CLINER

  • Contaminated waste container
The Stratus® CS Acute Care(TM) D-dimer Dilution Pak (DDMR DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care(TM) DDMR TestPak for the measurement of samples with elevated levels of D-dimer.
Siemens Healthcare Diagnostics Inc.
10445077
In Commercial Distribution

  • 00842768004582 ()
  • 00630414009902 ()
CDDMR-D

  • D-dimer IVD, kit, fluorescent immunoassay
The Stratus® CS Acute Care™ DDMR Calibrator (DDMR CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care™ DDMR method
Siemens Healthcare Diagnostics Inc.
10445076
In Commercial Distribution

  • 00842768004575 ()
  • 00630414009896 ()
CDDMR-C

  • D-dimer IVD, kit, fluorescent immunoassay
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