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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Aspartate Aminotransferase Flex® reagent cartridge, 360 tests
Siemens Healthcare Diagnostics Inc.
10444959
In Commercial Distribution

  • 00842768005558 ()
  • 00630414004426 ()
DF41A

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Glucose Flex® reagent cartridge, 1440 tests
Siemens Healthcare Diagnostics Inc.
10444971
In Commercial Distribution

  • 00842768005541 ()
  • 00630414004501 ()
DF40

  • Glucose IVD, kit, spectrophotometry
C-Reactive Protein Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444894
Not in Commercial Distribution

  • 00842768005527 ()
  • 00630414003856 ()
DF37

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Digitoxin Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444932
In Commercial Distribution

  • 00842768005510 ()
  • 00630414004174 ()
DF36

  • Digitoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Ecstasy Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445477
In Commercial Distribution

  • 00842768002229 ()
9X029UL

  • Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Methaqualone Assay, 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445475
In Commercial Distribution

  • 00842768002212 ()
9Q129UL

  • Methaqualone IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Methaqualone Assay, 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445473
In Commercial Distribution

  • 00842768002205 ()
9Q029UL

  • Methaqualone IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Cannabinoid Assay - 1L Kit
Siemens Healthcare Diagnostics Inc.
10445471
In Commercial Distribution

  • 00842768002199 ()
9N129UL

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Cannabinoid Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445469
In Commercial Distribution

  • 00842768002182 ()
9N029UL

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® 5B3 THC Calibrator 50
Siemens Healthcare Diagnostics Inc.
10445466
Not in Commercial Distribution

  • 00842768002151 ()
9M839UL

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
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