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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Salt Bridge Solution, 3x150mL
Siemens Healthcare Diagnostics Inc.
10444873
In Commercial Distribution

  • 00842768004735 ()
  • 00630414003788 ()
D105

  • Ion selective electrode (ISE) reference solution IVD, reagent
Stratus® CS STAT Fluorometric Analyzer Pipette Tips are in vitro diagnostics devices which are intended to be used on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10445089
In Commercial Distribution

  • 00842768004681 ()
  • 00630414009995 ()
CTIP

  • Pipette tip
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™ NT-proBNP Dilution Pak (pBNP DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ pBNP TestPak on the Stratus® CS analyzer for the measurement of samples with elevated levels of NT-proBNP.
Siemens Healthcare Diagnostics Inc.
10445085
In Commercial Distribution

  • 00842768004667 ()
  • 00630414009957 ()
CPBNP-D

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay
The Stratus® CS Acute Care(TM) Myoglobin Dilution Pak (MYO DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care(TM) MYO TestPak for the measurement of samples with elevated levels of Myoglobin.
Siemens Healthcare Diagnostics Inc.
10445081
In Commercial Distribution

  • 00842768004629 ()
  • 00630414009940 ()
CMYO-D

  • Myoglobin IVD, kit, fluorescent immunoassay
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
The Stratus® CS Acute Care(TM) Myoglobin (MYO) method is an in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma.
Siemens Healthcare Diagnostics Inc.
10445079
In Commercial Distribution

  • 00842768004605 ()
  • 00630414009926 ()
CMYO

  • 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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