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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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The Stratus® CS Acute Care™ CardioPhase® High Sensitivity C-reactive Protein Calibrator (CCRP CalPak) is an in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10445067
In Commercial Distribution

  • 00842768004476 ()
  • 00630414009810 ()
CCCRP-C

  • C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP method (hsCRP) is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma and is intended to be used on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10445066
In Commercial Distribution

  • 00842768004469 ()
  • 00630414009803 ()
CCCRP

  • C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
Syva® RapidTest d.a.u.® 10 mAMP/OPI/COC/THC/PCP/BZO/BAR/MDN/TCA/AMP
Siemens Healthcare Diagnostics Inc.
10445363
In Commercial Distribution

  • 00842768001345 ()
  • 00630414013978 ()
6A289UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 9 mAMP / OPI / COC / THC / PCP / BZO / BAR / TCA / AMP
Siemens Healthcare Diagnostics Inc.
10445362
Not in Commercial Distribution

  • 00842768001338 ()
  • 00630414013961 ()
6A279UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 8 THC / OPI / COC / mAMP / BZO / BAR / TCA / PCP
Siemens Healthcare Diagnostics Inc.
10445361
Not in Commercial Distribution

  • 00842768001321 ()
  • 00630414013954 ()
6A269UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 5 mAMP / OPI / COC / THC / PCP
Siemens Healthcare Diagnostics Inc.
10445360
In Commercial Distribution

  • 00842768001314 ()
  • 00630414013947 ()
6A259UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 4 THC / OPI / COC / AMP
Siemens Healthcare Diagnostics Inc.
10445359
In Commercial Distribution

  • 00842768001307 ()
  • 00630414013923 ()
6A199UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 3 THC / COC / OPI
Siemens Healthcare Diagnostics Inc.
10445358
In Commercial Distribution

  • 00842768001291 ()
  • 00630414013916 ()
6A179UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest™ Tricyclic Antidepressants TCA
Siemens Healthcare Diagnostics Inc.
10445355
In Commercial Distribution

  • 00842768001277 ()
  • 00630414013879 ()
6A119UL

  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® Methadone MDN
Siemens Healthcare Diagnostics Inc.
10445354
In Commercial Distribution

  • 00842768001260 ()
  • 00630414013862 ()
6A109UL

  • Methadone IVD, kit, rapid ICT, clinical
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