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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Low-Density Lipoprotein Cholesterol Flex® reagent cartridge, 180 Tests
Siemens Healthcare Diagnostics Inc.
10445096
In Commercial Distribution

  • 00842768015267 ()
  • 00630414004716 ()
K3131

  • Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry
Lactic Acid Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445153
In Commercial Distribution

  • 00842768015243 ()
  • 00630414005171 ()
K3016

  • Lactate IVD, kit, spectrophotometry
Iron Flex® reagent cartridge, 240 tests
Siemens Healthcare Diagnostics Inc.
10445135
In Commercial Distribution

  • 00842768015236 ()
  • 00630414005058 ()
K3085

  • Iron IVD, kit, spectrophotometry
Gamma Glutamyl Transferase Flex® reagent cartridge, 420 tests
Siemens Healthcare Diagnostics Inc.
10445150
In Commercial Distribution

  • 00842768015229 ()
  • 00630414005157 ()
K2045

  • Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry
Gentamicin Flex® reagent cartridge, 40 tests
Siemens Healthcare Diagnostics Inc.
10445120
In Commercial Distribution

  • 00842768015212 ()
  • 00630414004938 ()
K4012

  • Gentamicin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Free Thyroxine Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10445103
In Commercial Distribution

  • 00842768015205 ()
  • 00630414004778 ()
K6410

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Free Triiodothyronine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445106
In Commercial Distribution

  • 00842768015199 ()
  • 00630414004792 ()
K6416

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Ferritin Flex® reagent cartridge, 320 tests
Siemens Healthcare Diagnostics Inc.
10445136
In Commercial Distribution

  • 00842768015182 ()
  • 00630414005065 ()
K6440

  • Ferritin IVD, kit, chemiluminescent immunoassay
Cardiac Troponin I Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445098
Not in Commercial Distribution

  • 00842768015151 ()
  • 00630414004730 ()
K6421

  • Troponin I IVD, kit, chemiluminescent immunoassay
Cyclosporine Flex® reagent cartridge, 60 tests
Siemens Healthcare Diagnostics Inc.
10445139
Not in Commercial Distribution

  • 00842768015144 ()
  • 00630414005089 ()
K4089

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Carbamazepine Flex® reagent cartridgem, 80 tests
Siemens Healthcare Diagnostics Inc.
10445129
In Commercial Distribution

  • 00842768015137 ()
  • 00630414005003 ()
K4087

  • Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Urine Cocaine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445113
In Commercial Distribution

  • 00842768015120 ()
  • 00630414004860 ()
K5092

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
Cholesterol Flex® reagent cartridge, 600 tests
Siemens Healthcare Diagnostics Inc.
10445143
In Commercial Distribution

  • 00842768015090 ()
  • 00630414005102 ()
K1027

  • Total cholesterol lipid IVD, kit, spectrophotometry
Urine Benzodiazepines Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445118
In Commercial Distribution

  • 00842768015083 ()
  • 00630414004914 ()
K5097

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Urine Barbiturates Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445117
In Commercial Distribution

  • 00842768015076 ()
  • 00630414004907 ()
K5096

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
Amylase Flex® reagent cartridge, 360 tests
Siemens Healthcare Diagnostics Inc.
10445154
In Commercial Distribution

  • 00842768015069 ()
  • 00630414005188 ()
K3017

  • Total amylase IVD, kit, spectrophotometry
Urine Amphetamine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445112
In Commercial Distribution

  • 00842768015052 ()
  • 00630414004853 ()
K5091

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Albumin Flex® reagent cartridge, 1200 tests
Siemens Healthcare Diagnostics Inc.
10445165
In Commercial Distribution

  • 00842768015021 ()
  • 00630414005256 ()
K1013

  • Albumin IVD, kit, spectrophotometry
Acetaminophen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445110
In Commercial Distribution

  • 00842768015014 ()
  • 00630414004839 ()
K5088

  • Acetaminophen 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 Methaqualone Assay, 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445474
In Commercial Distribution

  • 00842768014437 ()
9Q039UL

  • Methaqualone 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)
Syva® Emit® II Plus Ethyl Alcohol Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445446
In Commercial Distribution

  • 00842768014413 ()
9K039UL

  • Ethanol (ETOH) IVD, kit, spectrophotometry
Syva® Emit® II Plus Phencyclidine Assay - 29 mL Kit
Siemens Healthcare Diagnostics Inc.
10445442
In Commercial Distribution

  • 00842768014406 ()
9J039UL

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Cocaine Metabolite Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445438
In Commercial Distribution

  • 00842768014390 ()
9H039UL

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
Alkaline Phosphatase Calibrator, 3 x 1mL
Siemens Healthcare Diagnostics Inc.
10714029
In Commercial Distribution

  • 00842768039041 ()
KC331

  • Alkaline phosphatase (ALP) isoenzyme IVD, calibrator
Alkaline Phosphatase Flex® reagent cartridge, 1600 tests
Siemens Healthcare Diagnostics Inc.
10642444
In Commercial Distribution

  • 00842768039034 ()
  • 00630414005942 ()
K2115

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry
Alkaline Phosphatase calibrator, 3x2x1mL
Siemens Healthcare Diagnostics Inc.
10714028
In Commercial Distribution

  • 00842768039027 ()
DC150

  • Alkaline phosphatase (ALP) isoenzyme IVD, calibrator
Alkaline Phosphatase Flex® reagent cartridge, 360 tests
Siemens Healthcare Diagnostics Inc.
10642445
In Commercial Distribution

  • 00842768039010 ()
  • 00630414005959 ()
DF150

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry
Dimension Vista® ACLN Flex® reagent cartridge, 4 Flex® reagent cartridges per carton
Siemens Healthcare Diagnostics Inc.
10712182
In Commercial Distribution

  • 00842768037771 ()
  • 00630414016795 ()
KS343

  • Wash/cleaning solution IVD, automated/semi-automated system
Dimension® EXL™ Total Vitamin D, 200 tests (4x50)
Siemens Healthcare Diagnostics Inc.
10706480
In Commercial Distribution

  • 00842768037740 ()
  • 00630414016801 ()
RF634

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
LOCI High-Sensitivity Troponin I (TNIH)
Siemens Healthcare Diagnostics Inc.
10471068
In Commercial Distribution

  • 00842768037726 ()
  • 00630414225203 ()
RF627

  • Troponin I IVD, kit, chemiluminescent immunoassay
High-Sensitivity Troponin (TNIH) Dimension Vista - RGT 120T
Siemens Healthcare Diagnostics Inc.
10471067
In Commercial Distribution

  • 00842768037719 ()
  • 00630414225197 ()
K6427

  • Troponin I IVD, kit, chemiluminescent immunoassay
LOCI Cardiac Troponin-I Control (high), 12 vials x2.2mL
Siemens Healthcare Diagnostics Inc.
10707958
Not in Commercial Distribution

  • 00842768037535 ()
  • 00630414006017 ()
KC683

  • Troponin I IVD, control
LOCI Cardiac Troponin-I Control (medium), 12 vials x2.2mL
Siemens Healthcare Diagnostics Inc.
10707957
Not in Commercial Distribution

  • 00842768037528 ()
  • 00630414006000 ()
KC682

  • Troponin I IVD, control
LOCI Cardiac Troponin-I Control (low), 12 vials x2.2mL
Siemens Healthcare Diagnostics Inc.
10707956
Not in Commercial Distribution

  • 00842768037511 ()
  • 00630414005997 ()
KC681

  • Troponin I IVD, control
Dimension® EXL™ 200 System
Siemens Healthcare Diagnostics Inc.
10636928
In Commercial Distribution

  • 00842768037214 ()
778041.931

  • Multiple clinical chemistry analyser IVD, laboratory
Enzymatic Creatinine Flex® reagent cartridge, 800 Tests
Siemens Healthcare Diagnostics Inc.
10700444
In Commercial Distribution

  • 00842768036262 ()
  • 00630414005973 ()
K1270A

  • Creatinine IVD, kit, spectrophotometry
Mycophenolic Acid Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10706859
In Commercial Distribution

  • 00842768036217 ()
DF215

  • Mycophenolate therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Tacrolimus Calibrator, Levels 1-5, 2 bottles each
Siemens Healthcare Diagnostics Inc.
10700796
In Commercial Distribution

  • 00842768035432 ()
DC207

  • Tacrolimus therapeutic drug monitoring IVD, calibrator
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