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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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Stratus® CS - 00842768024863

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

Syva® Emit® II 5B3 THC Assay - 00842768023910

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 - 00842768023460

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 - 00842768023453

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 - 00842768023446

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 - 00842768023439

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 Cocaine Metabolite Assay - 00842768023415

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),

Emit® II Plus Propoxyphene Assay - 00842768023408

Emit ® II Plus Propoxyphene Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445436
In Commercial Distribution

  • 00842768023408 ()
9G229

  • Propoxyphene IVD, kit, enzyme immunoassay (EIA)

Emit® II Plus Benzodiazepine Assay - 00842768023392

Emit ® II Plus Benzodiazepine Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445432
In Commercial Distribution

  • 00842768023392 ()
9F229

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

Emit® II Plus Methadone Assay - 00842768023385

Emit ® II Plus Methadone Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445231
In Commercial Distribution

  • 00842768023385 ()
9E229

  • Methadone IVD, kit, enzyme immunoassay (EIA)
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