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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Albumin Flex® reagent cartridge, 1200 tests
Siemens Healthcare Diagnostics Inc.
10445165
In Commercial Distribution

  • 00842768015021 ()
  • 00630414005256 ()
K1013

  • Albumin IVD, kit, spectrophotometry
Urine Ecstasy Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444921
In Commercial Distribution

  • 00842768014710 ()
  • 00630414004075 ()
DF109

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Cannabinoid Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445470
In Commercial Distribution

  • 00842768014420 ()
9N039UL

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Uric Acid Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444967
In Commercial Distribution

  • 00842768014192 ()
  • 00630414004488 ()
DF77

  • Uric acid IVD, kit, spectrophotometry
Pseudocholinesterase Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444964
In Commercial Distribution

  • 00842768014178 ()
  • 00630414004464 ()
DF51

  • Pseudocholinesterase IVD, kit, spectrophotometry
C-Reactive Protein Extended Range Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444903
In Commercial Distribution

  • 00842768014130 ()
  • 00630414003917 ()
DF34

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Urea Nitrogen Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444969
In Commercial Distribution

  • 00842768014116 ()
  • 00630414004495 ()
DF21

  • Urea IVD, kit, enzyme spectrophotometry
Dimension® Sample Transfer Module Aliquot Segments
Siemens Healthcare Diagnostics Inc.
10445571
In Commercial Distribution

  • 00842768014048 ()
  • 00630414024547 ()
STM2

  • General specimen container IVD, no additive/medium
Quiklyte Diluent Check, 60mL
Siemens Healthcare Diagnostics Inc.
10444872
In Commercial Distribution

  • 00842768014024 ()
S640

  • Multiple electrolyte IVD, reagent
QuikLYTE® Integrated Multisensor Standard A, 3x1 Liter
Siemens Healthcare Diagnostics Inc.
10444878
In Commercial Distribution

  • 00842768013997 ()
  • 00630414003801 ()
S620

  • Multiple electrolyte IVD, calibrator
Small Sample Container (SSC) - Dimension® - 1000 Pieces
Siemens Healthcare Diagnostics Inc.
10445040
In Commercial Distribution

  • 00842768005909 ()
  • 00630414004662 ()
DSC5

  • Assay container IVD, single-use
EMPTY Flex® reagent cartridge, 8 Flex
Siemens Healthcare Diagnostics Inc.
10445039
In Commercial Distribution

  • 00842768005886 ()
  • 00630414004655 ()
DF99

  • Assay container IVD, single-use
Urine Benzodiazepines Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444919
In Commercial Distribution

  • 00842768005879 ()
  • 00630414004051 ()
DF97A

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Urine Barbiturates Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444918
In Commercial Distribution

  • 00842768005862 ()
  • 00630414004044 ()
DF96A

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
Urine Cannabinoids Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444925
In Commercial Distribution

  • 00842768005855 ()
  • 00630414004112 ()
DF95A

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Urine Phencyclidine Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444924
In Commercial Distribution

  • 00842768005848 ()
  • 00630414004105 ()
DF94A

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Urine Opiates Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444923
In Commercial Distribution

  • 00842768005831 ()
  • 00630414004099 ()
DF93A

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
Urine Cocaine Metabolite Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444920
In Commercial Distribution

  • 00842768005824 ()
  • 00630414004068 ()
DF92A

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
Urine Amphetamine/Methamphetamine Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444926
In Commercial Distribution

  • 00842768005817 ()
  • 00630414004129 ()
DF91B

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Urine Methadone Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444922
In Commercial Distribution

  • 00842768005800 ()
  • 00630414004082 ()
DF90A

  • Methadone IVD, kit, enzyme immunoassay (EIA)
Acetaminophen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444916
In Commercial Distribution

  • 00842768005787 ()
  • 00630414004037 ()
DF88

  • Acetaminophen IVD, kit, spectrophotometry
Carbamazepine Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444930
In Commercial Distribution

  • 00842768005770 ()
  • 00630414004167 ()
DF87

  • Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Vancomycin Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444929
In Commercial Distribution

  • 00842768005763 ()
  • 00630414004150 ()
DF86

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Total Iron Binding Capacity Flex® reagent cartridge, 240 tests
Siemens Healthcare Diagnostics Inc.
10444944
In Commercial Distribution

  • 00842768005756 ()
  • 00630414004310 ()
DF84

  • Total iron binding capacity (TIBC) IVD, kit, spectrophotometry
Immunoglobulin M Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444984
In Commercial Distribution

  • 00842768005732 ()
  • 00630414004600 ()
DF81

  • Immunoglobulin M subclass (IgM subclass) IVD, kit, nephelometry/turbidimetry
Prealbumin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444978
In Commercial Distribution

  • 00842768005725 ()
  • 00630414004549 ()
DF80

  • Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry
Valproic Acid Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444943
In Commercial Distribution

  • 00842768005718 ()
  • 00630414004303 ()
DF78

  • Valproic acid therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Immunoglobulin G Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444983
In Commercial Distribution

  • 00842768005701 ()
  • 00630414004594 ()
DF76

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
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
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
Cholesterol Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444891
In Commercial Distribution

  • 00842768005466 ()
  • 00630414003849 ()
DF27

  • Total cholesterol lipid IVD, kit, spectrophotometry
Salicylate Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444915
In Commercial Distribution

  • 00842768005435 ()
  • 00630414004020 ()
DF20

  • Salicylate IVD, kit, spectrophotometry
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