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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Dimension® EXL™/ Dimension Vista® Multi 2 sample diluent, 6x2.5mL
Siemens Healthcare Diagnostics Inc.
10483586
In Commercial Distribution

  • 00842768032417 ()
  • 00630414005799 ()
KD694

  • Buffered sample diluent IVD
LOCI Thyroid Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10484354
In Commercial Distribution

  • 00842768031694 ()
RC610A

  • Multiple thyroid marker IVD, calibrator
Creatine Kinase Flex® reagent cartridge, 800 Tests
Siemens Healthcare Diagnostics Inc.
10464356
In Commercial Distribution

  • 00842768027925 ()
  • 00630414005607 ()
K2038

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 120 Tests
Siemens Healthcare Diagnostics Inc.
10464339
In Commercial Distribution

  • 00842768027918 ()
  • 00630414005577 ()
K3032

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Lactate Dehydrogenase Flex® reagent cartridge, 800 Tests
Siemens Healthcare Diagnostics Inc.
10464323
In Commercial Distribution

  • 00842768027819 ()
  • 00630414005539 ()
K2054

  • Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry
ADVIA 120/2120/2120i RBC Flow Cell Wash Kit
Siemens Healthcare Diagnostics Inc.
10734561
In Commercial Distribution

  • 00630414286938 ()
  • 00842768027369 ()
10734561

  • Wash/cleaning solution IVD, automated/semi-automated system
ADVIA 120/2120/2120i Perox Flow Cell Wash Kit
Siemens Healthcare Diagnostics Inc.
11306489
In Commercial Distribution

  • 00630414287089 ()
  • 00842768027345 ()
11306489

  • Wash/cleaning solution IVD, automated/semi-automated system
ADVIA 120/2120/2120i Aspiration Pathway Wash Kit
Siemens Healthcare Diagnostics Inc.
11306490
In Commercial Distribution

  • 00630414287096 ()
  • 00842768027338 ()
11306490

  • Wash/cleaning solution IVD, automated/semi-automated system
Lactate Dehydrogenase Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10284483
In Commercial Distribution

  • 00842768027314 ()
  • 00630414002965 ()
DF54

  • Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry
Drug 3 Calibrator- Level A - 6x2mL, Level B 3x1.5ml, Level C 3X1.5 mL
Siemens Healthcare Diagnostics Inc.
10285194
Not in Commercial Distribution

  • 00842768025211 ()
KC430A

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
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