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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® Testosterone Calibrator - 00630414948775

Testosterone Calibrator, 12 (2A x 1.0 mL; 2B x 1.0 mL; 2C x 1.0 mL; 2D x 1.0 mL; 2E x 1.0 mL; 2F x 1.0 mL)
Siemens Healthcare Diagnostics Inc.
10712611
In Commercial Distribution

  • 00630414948775 ()
KC638

  • Total testosterone IVD, calibrator

Dimension Vista® PROG Calibrator - 00630414948768

Progesterone Calibrator, 10 (2A x 1.0 mL; 2B x 1.0 mL; 2C x 1.0 mL;2D x 1.0 mL; 2E x 1.0 mL)
Siemens Healthcare Diagnostics Inc.
10712610
In Commercial Distribution

  • 00630414948768 ()
KC637

  • Progesterone IVD, calibrator

Dimension Vista® CHEM 1 CAL - 00630414948508

Chemistry 1 Calibrator, 6 (3A x 2.3 mL; 3B x 2.3 mL)
Siemens Healthcare Diagnostics Inc.
10716281
Not in Commercial Distribution

  • 00630414948508 ()
KC110B

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension® CHEM I CAL - 00630414948492

Chemistry I Calibrator, 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10716280
In Commercial Distribution

  • 00630414948492 ()
DC18C

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® Flex® reagent cartridge AMM - 00630414948102

Ammonia Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10711992
In Commercial Distribution

  • 00630414948102 ()
  • 00630414006093 ()
K3119

  • Ammonia IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge AMM - 00630414948096

Ammonia Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10711991
In Commercial Distribution

  • 00630414948096 ()
  • 00630414006086 ()
DF119

  • Ammonia IVD, kit, spectrophotometry

Dimension® CHEM III CAL - 00630414948034

Chemistry III Calibrator, 3x2x2.5mL
Siemens Healthcare Diagnostics Inc.
10711580
In Commercial Distribution

  • 00630414948034 ()
DC130

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® CHEM 3 CAL - 00630414948027

Chemistry 3 Calibrator, 6 (3A x 2.5 mL; 3B x 2.5 mL)
Siemens Healthcare Diagnostics Inc.
10711579
In Commercial Distribution

  • 00630414948027 ()
KC130A

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

IMMULITE Systems Unconjugated Estriol (uE3) CVM - 00630414947921

No Description
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10707265
In Commercial Distribution

  • 00630414947921 ()
LUE3CVM(D)

  • Free estriol (oestriol) IVD, control

IMMULITE® 2000 Systems E2 Estradiol - 00630414947914

No Description
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10702834
In Commercial Distribution

  • 00630414947914 ()
L2KE26(D)

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
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