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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 Acute Care™ ßhCG TestPak - 00842768004407

The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin method (ßhCG) is an in vitro diagnostic test for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free ß subunit, of the human chorionic gonadotropin hormone in heparinized plasma.
Siemens Healthcare Diagnostics Inc.
10445060
In Commercial Distribution

  • 00842768004407 ()
  • 00630414009759 ()
CBHCG

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay

Syva® Emit® Ethyl Alcohol Low Control - 00842768001987

Syva® Emit® Ethyl Alcohol Low Control
Siemens Healthcare Diagnostics Inc.
10445447
In Commercial Distribution

  • 00842768001987 ()
9K049UL

  • Ethanol (ETOH) IVD, control

Syva® Emit® Ethyl Alcohol Negative Calibrator - 00842768001970

Syva® Emit® Ethyl Alcohol Negative Calibrator
Siemens Healthcare Diagnostics Inc.
10445445
In Commercial Distribution

  • 00842768001970 ()
9K029UL

  • Ethanol (ETOH) IVD, calibrator

Syva® Emit® II Plus Phencyclidine Assay - 00842768001956

Syva® Emit® II Plus Phencyclidine Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445441
In Commercial Distribution

  • 00842768001956 ()
9J029UL

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Cocaine Metabolite Assay - 00842768001932

Syva® Emit® II Plus Cocaine Metabolite Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445437
In Commercial Distribution

  • 00842768001932 ()
9H029UL

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

Syva® Emit® II Plus Propoxyphene Assay - 00842768001925

Syva® Emit® II Plus Propoxyphene Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445435
In Commercial Distribution

  • 00842768001925 ()
9G129UL

  • Propoxyphene IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Propoxyphene Assay - 00842768001918

Syva® Emit® II Plus Propoxyphene Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445433
In Commercial Distribution

  • 00842768001918 ()
9G029UL

  • Propoxyphene IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Benzodiazepine Assay - 00842768001901

Syva® Emit® II Plus Benzodiazepine Assay - 1L Kit
Siemens Healthcare Diagnostics Inc.
10445431
In Commercial Distribution

  • 00842768001901 ()
9F129UL

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

Syva® Emit® II Plus Barbiturate Assay - 00842768001888

Syva® Emit® II Plus Barbiturate Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445424
In Commercial Distribution

  • 00842768001888 ()
9D129UL

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Barbiturate Assay - 00842768001871

Syva® Emit® II Plus Barbiturate Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445422
In Commercial Distribution

  • 00842768001871 ()
9D029UL

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Amphetamines Assay - 00842768001864

Syva® Emit® II Plus Amphetamines Assay - 1L Kit
Siemens Healthcare Diagnostics Inc.
10445421
In Commercial Distribution

  • 00842768001864 ()
9C329UL

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Amphetamines Assay - 00842768001857

Syva® Emit® II Plus Amphetamines Assay - 115 mL
Siemens Healthcare Diagnostics Inc.
10445420
In Commercial Distribution

  • 00842768001857 ()
9C309UL

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Opiate Assay - 00842768001826

Syva® Emit® II Plus Opiate Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445417
In Commercial Distribution

  • 00842768001826 ()
9B329UL

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Opiate Assay - 00842768001819

Syva® Emit® II Plus Opiate Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445416
In Commercial Distribution

  • 00842768001819 ()
9B309UL

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® Calibrator B Level 2 (high) - 00842768001802

Syva® Emit® Calibrator B Level 2 (high)
Siemens Healthcare Diagnostics Inc.
10445413
In Commercial Distribution

  • 00842768001802 ()
9A899UL

  • Amphetamine/methamphetamine group IVD, calibrator

Syva® Emit® Calibrator B Level 1 (cutoff) - 00842768001796

Syva® Emit® Calibrator B Level 1 (cutoff)
Siemens Healthcare Diagnostics Inc.
10445412
In Commercial Distribution

  • 00842768001796 ()
9A879UL

  • Amphetamine/methamphetamine group IVD, calibrator

Syva® Emit® Calibrator/Control Level 5 - 00842768001789

Syva® Emit® Calibrator/Control Level 5
Siemens Healthcare Diagnostics Inc.
10445411
In Commercial Distribution

  • 00842768001789 ()
9A609UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® Calibrator/Control Level 4 - 00842768001772

Syva® Emit® Calibrator/Control Level 4
Siemens Healthcare Diagnostics Inc.
10445410
In Commercial Distribution

  • 00842768001772 ()
9A589UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® Calibrator/Control Level 3 - 00842768001765

Syva® Emit® Calibrator/Control Level 3
Siemens Healthcare Diagnostics Inc.
10445409
In Commercial Distribution

  • 00842768001765 ()
9A569UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® Calibrator/Control Level 2 - 00842768001758

Syva® Emit® Calibrator/Control Level 2
Siemens Healthcare Diagnostics Inc.
10445408
In Commercial Distribution

  • 00842768001758 ()
9A549UL

  • Multiple drugs of abuse IVD, calibrator
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