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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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IMMULITE® Systems ACT CONTROL ACTH - 00630414953090

ACTH - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385382
In Commercial Distribution

  • 00630414953090 ()
LACCM

  • Adrenocorticotropic hormone (ACTH) IVD, control

Dimension Vista® 500 - 00630414949581

DIMENSION® VISTA® 500 Instrument
Siemens Healthcare Diagnostics Inc.
10284473
In Commercial Distribution

  • 00630414949581 ()
1000036563

  • Multiple clinical chemistry analyser IVD, laboratory

Dimension Vista® 1500 Intelligent Lab System - 00630414949536

Dimension Vista® 1500 Intelligent Lab System
Siemens Healthcare Diagnostics Inc.
10459469
In Commercial Distribution

  • 00630414949536 ()
1000033793

  • Multiple clinical chemistry analyser IVD, laboratory

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

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

IMMULITE® 2000 Systems E2 Estradiol - 00630414947907

No Description
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10702833
In Commercial Distribution

  • 00630414947907 ()
L2KE22(D)

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

IMMULITE®/IMMULITE® 1000 Systems E2 Estradiol - 00630414947891

No Description
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10702832
In Commercial Distribution

  • 00630414947891 ()
LKE21(D)

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

IMMULITE® 1000 Immunoassay System - 00630414947440

IMMULITE® 1000 Instrument, 110 VOLT
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10380058
In Commercial Distribution

  • 00630414947440 ()
030006-03

  • Chemiluminescent immunoassay analyser IVD
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