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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Thyronine Uptake Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10444912
In Commercial Distribution

  • 00842768005695 ()
  • 00630414003993 ()
DF75A

  • Thyroxine binding globulin (TBG) IVD, kit enzyme immunoassay (EIA)
Immunoglobulin A Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444982
In Commercial Distribution

  • 00842768005688 ()
  • 00630414004587 ()
DF74

  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry
Total Protein Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444979
In Commercial Distribution

  • 00842768005671 ()
  • 00630414004556 ()
DF73

  • Total protein IVD, kit, spectrophotometry
Theophylline Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444942
In Commercial Distribution

  • 00842768005664 ()
  • 00630414004297 ()
DF71

  • Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Triglycerides Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444906
In Commercial Distribution

  • 00842768005657 ()
  • 00630414003948 ()
DF69A

  • Triglyceride IVD, kit, spectrophotometry
Thyroxine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444908
In Commercial Distribution

  • 00842768005626 ()
  • 00630414003962 ()
DF65

  • Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)
Phenytoin Flex® reagent cartridge, 112 tests
Siemens Healthcare Diagnostics Inc.
10444940
In Commercial Distribution

  • 00842768005619 ()
  • 00630414004273 ()
DF64

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Phenobarbital Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444933
In Commercial Distribution

  • 00842768005596 ()
  • 00630414004181 ()
DF60

  • Phenobarbital IVD, kit, nephelometry/turbidimetry
Aspartate Aminotransferase Flex® reagent cartridge, 360 tests
Siemens Healthcare Diagnostics Inc.
10444959
In Commercial Distribution

  • 00842768005558 ()
  • 00630414004426 ()
DF41A

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Glucose Flex® reagent cartridge, 1440 tests
Siemens Healthcare Diagnostics Inc.
10444971
In Commercial Distribution

  • 00842768005541 ()
  • 00630414004501 ()
DF40

  • Glucose IVD, kit, spectrophotometry
C-Reactive Protein Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444894
Not in Commercial Distribution

  • 00842768005527 ()
  • 00630414003856 ()
DF37

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Digitoxin Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444932
In Commercial Distribution

  • 00842768005510 ()
  • 00630414004174 ()
DF36

  • Digitoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
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
Syva® Emit® LSD Control Level 2
Siemens Healthcare Diagnostics Inc.
10445461
In Commercial Distribution

  • 00842768002106 ()
9L519UL

  • Lysergic acid diethylamide (LSD)/LSD metabolite IVD, control
Syva® Emit® LSD Control Level 1
Siemens Healthcare Diagnostics Inc.
10445460
In Commercial Distribution

  • 00842768002090 ()
9L419UL

  • Lysergic acid diethylamide (LSD)/LSD metabolite IVD, control
Syva® Emit® LSD 2.5 ng/mL Calibrator
Siemens Healthcare Diagnostics Inc.
10445458
In Commercial Distribution

  • 00842768002083 ()
9L309UL

  • Lysergic acid diethylamide (LSD)/LSD metabolite IVD, calibrator
Syva® Emit® LSD 1.5 ng/mL Calibrator
Siemens Healthcare Diagnostics Inc.
10445457
In Commercial Distribution

  • 00842768002076 ()
9L209UL

  • Lysergic acid diethylamide (LSD)/LSD metabolite IVD, calibrator
Syva® Emit® LSD 0.5 ng/mL Calibrator
Siemens Healthcare Diagnostics Inc.
10445456
In Commercial Distribution

  • 00842768002069 ()
9L109UL

  • Lysergic acid diethylamide (LSD)/LSD metabolite IVD, calibrator
Syva® Emit® LSD 0 ng/mL Calibrator
Siemens Healthcare Diagnostics Inc.
10445454
In Commercial Distribution

  • 00842768002045 ()
9L009UL

  • Lysergic acid diethylamide (LSD)/LSD metabolite IVD, calibrator
Syva® Emit® II Plus Ethyl Alcohol Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445453
In Commercial Distribution

  • 00842768002038 ()
9K409UL

  • Ethanol (ETOH) IVD, kit, spectrophotometry
Syva® Emit® II Plus Ethyl Alcohol Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445452
In Commercial Distribution

  • 00842768002021 ()
9K309UL

  • Ethanol (ETOH) IVD, kit, spectrophotometry
Syva® Emit® Ethyl Alcohol High Control
Siemens Healthcare Diagnostics Inc.
10445449
In Commercial Distribution

  • 00842768002007 ()
9K079UL

  • Ethanol (ETOH) IVD, control
Syva® Emit ® Ethyl Alcohol 100 mg/dL Calibrator
Siemens Healthcare Diagnostics Inc.
10445448
In Commercial Distribution

  • 00842768001994 ()
9K059UL

  • Ethanol (ETOH) IVD, calibrator
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
Siemens Healthcare Diagnostics Inc.
10445445
In Commercial Distribution

  • 00842768001970 ()
9K029UL

  • Ethanol (ETOH) IVD, calibrator
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