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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Amylase Flex® reagent cartridge, 240 tests
Siemens Healthcare Diagnostics Inc.
10444965
In Commercial Distribution

  • 00842768005404 ()
  • 00630414004471 ()
DF17A

  • Total amylase IVD, kit, spectrophotometry
Lactic Acid Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444961
In Commercial Distribution

  • 00842768005398 ()
  • 00630414004440 ()
DF16

  • Lactate IVD, kit, spectrophotometry
Tobramycin Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444928
In Commercial Distribution

  • 00842768005381 ()
  • 00630414004143 ()
DF14

  • Tobramycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Enzymatic Carbonate Flex® reagent cartridge, 360 tests
Siemens Healthcare Diagnostics Inc.
10444972
In Commercial Distribution

  • 00842768005374 ()
  • 00630414004518 ()
DF137

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry
Lithium Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444939
In Commercial Distribution

  • 00842768005367 ()
  • 00630414004266 ()
DF132

  • Lithium therapeutic drug monitoring IVD, kit, spectrophotometry
Automated LDL Cholesterol Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444890
In Commercial Distribution

  • 00842768005350 ()
  • 00630414003832 ()
DF131

  • Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry
Albumin Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444975
In Commercial Distribution

  • 00842768005343 ()
  • 00630414004525 ()
DF13

  • Albumin IVD, kit, spectrophotometry
Gentamicin Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444927
In Commercial Distribution

  • 00842768005336 ()
  • 00630414004136 ()
DF12

  • Gentamicin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
N-Acetylprocainamide Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444936
In Commercial Distribution

  • 00842768005299 ()
  • 00630414004235 ()
DF111

  • N-acetyl procainamide (NAPA) IVD, kit, nephelometry/turbidimetry
Drug Calibrator II, 2x5x5mL
Siemens Healthcare Diagnostics Inc.
10445005
In Commercial Distribution

  • 00842768005176 ()
  • 00630414017082 ()
DC49D

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator
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