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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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
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
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