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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Enzymatic Creatinine Flex® reagent cartridge, 448 tests
Siemens Healthcare Diagnostics Inc.
10471520
In Commercial Distribution

  • 00842768030512 ()
  • 00630414005713 ()
DF270B

  • Creatinine IVD, kit, spectrophotometry
V-LYTE Integrated Multisensor
Siemens Healthcare Diagnostics Inc.
10484429
In Commercial Distribution

  • 00842768030413 ()
K800A

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
Multi 1 Sample Diluent, 12x2mL
Siemens Healthcare Diagnostics Inc.
10469971
In Commercial Distribution

  • 00842768030314 ()
  • 00630414005690 ()
KD693

  • Buffered sample diluent IVD
Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent
Siemens Healthcare Diagnostics Inc.
10488260
In Commercial Distribution

  • 00842768030048 ()
  • 00630414010526 ()
8S079UL

  • Multiple immunosuppressant therapeutic drug monitoring IVD, reagent
LOCI N-terminal Pro-Brain Natriuretic Peptide Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10464526
In Commercial Distribution

  • 00842768029912 ()
  • 00630414005683 ()
RF623

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay
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 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 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
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