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 Class Implantable

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Lactic Acid Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444961
In Commercial Distribution

  • 00842768005398 ()
  • 00630414004440 ()
DF16

  • Lactate 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
Drugs of Abuse Negative Control, 6x5mL
Siemens Healthcare Diagnostics Inc.
10445032
In Commercial Distribution

  • 00842768005145 ()
  • 00630414004624 ()
DC44A

  • Multiple drugs of abuse IVD, control
Drugs of Abuse Positive Control, 6x5mL
Siemens Healthcare Diagnostics Inc.
10445033
In Commercial Distribution

  • 00842768005138 ()
  • 00630414004631 ()
DC43A

  • Multiple drugs of abuse IVD, control
Pseudocholinesterase Verifier, 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10444987
In Commercial Distribution

  • 00842768005077 ()
  • 00630414016962 ()
DC28

  • Pseudocholinesterase IVD, control
Syva® Emit® Caffeine Control
Siemens Healthcare Diagnostics Inc.
10445372
In Commercial Distribution

  • 00842768001420 ()
6P499UL

  • Caffeine IVD, control
Dimension® EXL with LM system
Siemens Healthcare Diagnostics Inc.
10472176
In Commercial Distribution

  • 00842768030024 ()
778021.931

  • Multiple clinical chemistry analyser IVD, laboratory
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
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
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