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® 2000 Sirolimus Calibrators
Siemens Healthcare Diagnostics Inc.
10445402
In Commercial Distribution

  • 00842768029622 ()
8S109UL

  • Rapamycin (sirolimus) therapeutic drug monitoring IVD, calibrator
Syva® Emit® 2000 Sirolimus Assay
Siemens Healthcare Diagnostics Inc.
10445401
In Commercial Distribution

  • 00842768029615 ()
8S019UL

  • Rapamycin (sirolimus) therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
LOCI 7 Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10488446
In Commercial Distribution

  • 00842768029332 ()
KC605

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
LOCI 6 Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10488444
In Commercial Distribution

  • 00842768029325 ()
KC604

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Small Sample Container (SSC), 1000 Pieces
Siemens Healthcare Diagnostics Inc.
10472099
In Commercial Distribution

  • 00842768028915 ()
  • 00630414005720 ()
KS860

  • Assay container IVD, single-use
LOCI CA 19-9 Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10464358
In Commercial Distribution

  • 00842768028533 ()
  • 00630414005621 ()
K6457

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
LOCI CA 15-3 Flex® reagent cartridge, 160 Tests
Siemens Healthcare Diagnostics Inc.
10464344
In Commercial Distribution

  • 00842768028526 ()
  • 00630414005591 ()
K6456

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
LOCI CA 125 Flex® reagent cartridge, 160 Tests
Siemens Healthcare Diagnostics Inc.
10464357
In Commercial Distribution

  • 00842768028519 ()
  • 00630414005614 ()
K6455

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
LOCI Digoxin Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10488927
In Commercial Distribution

  • 00842768028335 ()
  • 00630414005843 ()
K6435

  • Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay
ADVIA 120/2120/2120i Vent Line Wash Kit
Siemens Healthcare Diagnostics Inc.
11306492
In Commercial Distribution

  • 00630414287102 ()
  • 00842768027307 ()
11306492

  • Wash/cleaning solution IVD, automated/semi-automated system
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