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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DM/VS Lipase Calibrator
Siemens Healthcare Diagnostics Inc.
10735073
Not in Commercial Distribution

  • 00842768026904 ()
DC56A

  • Lipase IVD, calibrator
Emit ® II Plus Benzodiazepine Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445432
In Commercial Distribution

  • 00842768023392 ()
9F229

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Emit ® II Plus Methadone Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445231
In Commercial Distribution

  • 00842768023385 ()
9E229

  • Methadone IVD, kit, enzyme immunoassay (EIA)
Emit ® II Plus Barbiturate Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445425
In Commercial Distribution

  • 00842768023378 ()
9D229

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
Emit ® II Plus Amphetamines Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445419
In Commercial Distribution

  • 00842768023361 ()
9C229

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
Emit® II Plus Opiate Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445415
In Commercial Distribution

  • 00842768023354 ()
9B229

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
Emit® tox Salicylic Acid Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445394
In Commercial Distribution

  • 00842768023347 ()
7S229

  • Salicylate IVD, kit, enzyme immunoassay (EIA)
Emit® tox Acetaminophen Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445384
In Commercial Distribution

  • 00842768023330 ()
7A229

  • Acetaminophen IVD, kit, enzyme immunoassay (EIA)
Emit® 2000 Vancomycin Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445338
In Commercial Distribution

  • 00842768023323 ()
4W229

  • Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit® 2000 Gentamicin Plus Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445335
In Commercial Distribution

  • 00842768023316 ()
4T229

  • Gentamicin therapeutic drug monitoring IVD, calibrator
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