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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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Dimension Vista® Flex® reagent cartridge HbA1c KIT - 00842768029974

HbA1c Kit containing Hemoglobin A1c Flex® reagent cartridge, 240 tests, and HbA1c Calibrator (5 levels)
Siemens Healthcare Diagnostics Inc.
10470481
Not in Commercial Distribution

  • 00842768029974 ()
  • 00630414005706 ()
K3105A

  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

Dimension® EXL™ LOCI® Module Flex® reagent cartridge LNTP - 00842768029929

N-terminal Pro-Brain Natriuretic Peptide Flex® reagent cartridge, 72 tests
Siemens Healthcare Diagnostics Inc.
10464338
In Commercial Distribution

  • 00842768029929 ()
  • 00630414005560 ()
RF723

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

Syva® Emit® 2000 Sirolimus Calibrators - 00842768029622

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

  • 00842768029622 ()
8S109UL

  • Rapamycin (sirolimus) therapeutic drug monitoring IVD, calibrator

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® 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® ALPI CAL - 00842768039041

Alkaline Phosphatase Calibrator, 3 x 1mL
Siemens Healthcare Diagnostics Inc.
10714029
In Commercial Distribution

  • 00842768039041 ()
KC331

  • Alkaline phosphatase (ALP) isoenzyme IVD, calibrator

Dimension Vista® Flex® reagent cartridge ALPI - 00842768039034

Alkaline Phosphatase Flex® reagent cartridge, 1600 tests
Siemens Healthcare Diagnostics Inc.
10642444
In Commercial Distribution

  • 00842768039034 ()
  • 00630414005942 ()
K2115

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry

Dimension® ALPI CAL - 00842768039027

Alkaline Phosphatase calibrator, 3x2x1mL
Siemens Healthcare Diagnostics Inc.
10714028
In Commercial Distribution

  • 00842768039027 ()
DC150

  • Alkaline phosphatase (ALP) isoenzyme IVD, calibrator

Dimension® Flex® reagent cartridge ALPI - 00842768039010

Alkaline Phosphatase Flex® reagent cartridge, 360 tests
Siemens Healthcare Diagnostics Inc.
10642445
In Commercial Distribution

  • 00842768039010 ()
  • 00630414005959 ()
DF150

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry
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