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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Urine Phencyclidine Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445115
In Commercial Distribution

  • 00842768015380 ()
  • 00630414004884 ()
K5094

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Pseudocholinesterase Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10445156
In Commercial Distribution

  • 00842768015373 ()
  • 00630414005195 ()
K3051

  • Pseudocholinesterase IVD, kit, spectrophotometry
Urine Opiate Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445114
In Commercial Distribution

  • 00842768015359 ()
  • 00630414004877 ()
K5093

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
N-Acetyl Procainamide Flex® reagent cartridge, 80 Tests
Siemens Healthcare Diagnostics Inc.
10445131
Not in Commercial Distribution

  • 00842768015342 ()
  • 00630414005027 ()
K4111

  • N-acetyl procainamide (NAPA) IVD, kit, nephelometry/turbidimetry
Myoglobin Flex® reagent cartridge, 100 tests
Siemens Healthcare Diagnostics Inc.
10445099
In Commercial Distribution

  • 00842768015335 ()
  • 00630414004747 ()
K6422

  • Myoglobin IVD, kit, chemiluminescent immunoassay
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 100 tests
Siemens Healthcare Diagnostics Inc.
10445097
In Commercial Distribution

  • 00842768015328 ()
  • 00630414004723 ()
K6420

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
Urine Methadone Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445111
In Commercial Distribution

  • 00842768015304 ()
  • 00630414004846 ()
K5090

  • Methadone IVD, kit, enzyme immunoassay (EIA)
Lidocaine Flex® reagent cartridge, 60 tests
Siemens Healthcare Diagnostics Inc.
10445132
In Commercial Distribution

  • 00842768015281 ()
  • 00630414005034 ()
K4113

  • Lidocaine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
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)
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