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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 STAT Fluorometric Analyzer is a microprocessor controlled instrument that measures analytes in body fluids for in vitro diagnostic use. The instrument is intended for use by trained healthcare professionals in the clinical laboratory and point of care settings and is intended for the measurement of the following analytes: High Sensitivity Troponin-I (CTNI), CK-MB Mass (Creatine kinase. MB) (CKMB), Myoglobin (MYO), NT-proBNP (PBNP), D-dimer (DDMR), CardioPhase hsCRP (High Sensitiv
Siemens Healthcare Diagnostics Inc.
10444834
In Commercial Distribution

  • 00842768024863 ()
758000.901

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
Dimension Vista Barcode Labels
Siemens Healthcare Diagnostics Inc.
10464353
In Commercial Distribution

  • 00842768024719 ()
KS866

  • Printer label IVD
Prostate Specific Antigen Calibrator
Siemens Healthcare Diagnostics Inc.
10464359
In Commercial Distribution

  • 00842768024214 ()
KC602

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Syva® Emit® II 5B3 THC Assay
Siemens Healthcare Diagnostics Inc.
10445468
Not in Commercial Distribution

  • 00842768023910 ()
9M979UL

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Emit® II Plus Ecstasy Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445479
In Commercial Distribution

  • 00842768023460 ()
9X229

  • Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Emit® II Plus Methaqualone Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445476
In Commercial Distribution

  • 00842768023453 ()
9Q229

  • Methaqualone IVD, kit, enzyme immunoassay (EIA)
Emit ® II Plus Cannabinoid Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445472
In Commercial Distribution

  • 00842768023446 ()
9N229

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Emit ® II Plus Ethyl Alcohol Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445451
In Commercial Distribution

  • 00842768023439 ()
9K229

  • Ethanol (ETOH) IVD, kit, spectrophotometry
Emit® II Plus Phencyclidine Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445444
In Commercial Distribution

  • 00842768023422 ()
9J229

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Emit ® II Plus Cocaine Metabolite Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445440
In Commercial Distribution

  • 00842768023415 ()
9H229

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
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