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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Syva® Emit® II Plus Amphetamines Assay - 1L Kit
Siemens Healthcare Diagnostics Inc.
10445421
In Commercial Distribution

  • 00842768001864 ()
9C329UL

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Amphetamines Assay - 115 mL
Siemens Healthcare Diagnostics Inc.
10445420
In Commercial Distribution

  • 00842768001857 ()
9C309UL

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® tox Acetaminophen Assay
Siemens Healthcare Diagnostics Inc.
10445385
In Commercial Distribution

  • 00842768001550 ()
7A319UL

  • Acetaminophen IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Amikacin Assay
Siemens Healthcare Diagnostics Inc.
10445383
In Commercial Distribution

  • 00842768001543 ()
6X019UL

  • Amikacin therapeutic drug monitoring 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® 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)
Syva® Emit ® d.a.u.® Amphetamine Class Assay
Siemens Healthcare Diagnostics Inc.
10445253
In Commercial Distribution

  • 00842768017148 ()
3C019UL

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
Urine Ecstasy Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445119
In Commercial Distribution

  • 00842768015557 ()
  • 00630414004921 ()
K5109

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
Uric Acid Flex® reagent cartridge, 560 tests
Siemens Healthcare Diagnostics Inc.
10445145
In Commercial Distribution

  • 00842768015519 ()
  • 00630414005126 ()
K1077

  • Uric acid IVD, kit, spectrophotometry
Urine Amphetamine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445112
In Commercial Distribution

  • 00842768015052 ()
  • 00630414004853 ()
K5091

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
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