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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 Size Device Size Type Device Class Implantable

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Syva® Emit® 2000 Sirolimus Assay - 00842768029615

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)

Dimension Vista® LOCI 7 CAL - 00842768029332

LOCI 7 Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10488446
In Commercial Distribution

  • 00842768029332 ()
KC605

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® LOCI 6 CAL - 00842768029325

LOCI 6 Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10488444
In Commercial Distribution

  • 00842768029325 ()
KC604

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® Small Sample Container (SSC) - 00842768028915

Small Sample Container (SSC), 1000 Pieces
Siemens Healthcare Diagnostics Inc.
10472099
In Commercial Distribution

  • 00842768028915 ()
  • 00630414005720 ()
KS860

  • Assay container IVD, single-use

Dimension Vista® Flex® reagent cartridge CA19-9 - 00842768028533

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

Dimension Vista® Flex® reagent cartridge CA15-3 - 00842768028526

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

Dimension Vista® Flex® reagent cartridge CA125 - 00842768028519

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

Dimension Vista® Flex® reagent cartridge DIGXN - 00842768028335

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

Dimension Vista® Flex® reagent cartridge CKI - 00842768027925

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

Dimension Vista® Flex® reagent cartridge MBI - 00842768027918

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)
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