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 Class Implantable

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Thyroxine Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10445101
In Commercial Distribution

  • 00842768015434 ()
  • 00630414004754 ()
K6065

  • Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)
Salicylate Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445108
In Commercial Distribution

  • 00842768015427 ()
  • 00630414004815 ()
K5020

  • Salicylate IVD, kit, spectrophotometry
Phenytoin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445125
In Commercial Distribution

  • 00842768015410 ()
  • 00630414004969 ()
K4064

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Procainamide Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445130
Not in Commercial Distribution

  • 00842768015403 ()
  • 00630414005010 ()
K4110

  • Procainamide therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Phenobarbital Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445124
In Commercial Distribution

  • 00842768015397 ()
  • 00630414004952 ()
K4060

  • Phenobarbital IVD, kit, nephelometry/turbidimetry
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
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