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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 CPE CONTROL C-Peptide - 00630414953007

C-Peptide - IMMULITE - CTL - 3x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385589
In Commercial Distribution

  • 00630414953007 ()
PECM

  • C-peptide 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® 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

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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