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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
Stratus® CS STAT Fluorometric Analyzer Sarstedt cannula holds the stoppered tube in the sample manager.
Siemens Healthcare Diagnostics Inc.
10445064
In Commercial Distribution

  • 00842768004445 ()
  • 00630414009797 ()
CCANS

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin Dilution Pak (ßhCG DilPak), in vitro diagnostic product intended to be used in conjunction with the Acute Care™ ßhCG TestPak on the Stratus® CS analyzer for the measurement of samples with elevated ßhCG levels.
Siemens Healthcare Diagnostics Inc.
10445062
In Commercial Distribution

  • 00842768004421 ()
  • 00630414009773 ()
CBHCG-D

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay
The Status® CS Acute Care(TM) Beta human Chorionic Gonadotropin CalPak calibrator (ßhCG CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care(TM) ßhCG method.
Siemens Healthcare Diagnostics Inc.
10445061
In Commercial Distribution

  • 00842768004414 ()
  • 00630414009766 ()
CBHCG-C

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay
Syva® Emit® II Plus Ecstasy Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445477
In Commercial Distribution

  • 00842768002229 ()
9X029UL

  • Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Methaqualone Assay, 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445475
In Commercial Distribution

  • 00842768002212 ()
9Q129UL

  • Methaqualone IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Methaqualone Assay, 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445473
In Commercial Distribution

  • 00842768002205 ()
9Q029UL

  • Methaqualone IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Cannabinoid Assay - 1L Kit
Siemens Healthcare Diagnostics Inc.
10445471
In Commercial Distribution

  • 00842768002199 ()
9N129UL

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Cannabinoid Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445469
In Commercial Distribution

  • 00842768002182 ()
9N029UL

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® 5B3 THC Calibrator 50
Siemens Healthcare Diagnostics Inc.
10445466
Not in Commercial Distribution

  • 00842768002151 ()
9M839UL

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
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