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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Amphetamine (Amp) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097506
In Commercial Distribution

  • 00630414596068 ()
11097506

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Barbiturates (Brb) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097507
In Commercial Distribution

  • 00630414596051 ()
11097507

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
Phenytoin (Phny) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097510
In Commercial Distribution

  • 00630414596037 ()
11097510

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Valproic Acid (VPA) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097512
In Commercial Distribution

  • 00630414596013 ()
11097512

  • Valproic acid therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Phenobarbital (Phnb) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097514
In Commercial Distribution

  • 00630414595993 ()
11097514

  • Phenobarbital IVD, kit, nephelometry/turbidimetry
Ecstasy (Xtc) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097518
In Commercial Distribution

  • 00630414595955 ()
11097518

  • Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Wash 1 Atellica IM - CONS 1 x 3000mL
Siemens Healthcare Diagnostics Inc.
11098501
In Commercial Distribution

  • 00630414595931 ()
11098501

  • Buffered wash solution IVD
IM Cleaner Atellica IM - CONS 2x 1.5L
Siemens Healthcare Diagnostics Inc.
11098502
In Commercial Distribution

  • 00630414595924 ()
  • 00630414211480 ()
11098502

  • Wash/cleaning solution IVD, automated/semi-automated system
Acetaminophen (Acet) Atellica CH - RGT 1200T
Siemens Healthcare Diagnostics Inc.
11097522
In Commercial Distribution

  • 00630414595894 ()
11097522

  • Acetaminophen IVD, kit, enzyme immunoassay (EIA)
Digoxin (Dgn) Atellica CH - RGT 1600T
Siemens Healthcare Diagnostics Inc.
11097526
In Commercial Distribution

  • 00630414595863 ()
11097526

  • Digoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
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