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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 2000 LH Kt Domestic 600T - 00630414167480

IMMULITE 2000 LH Kt Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901864
In Commercial Distribution

  • 00630414167480 ()
L2KLH6(D)

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

IMMULITE 2000 LH Kit Domestic 200T - 00630414167459

IMMULITE 2000 LH Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901863
In Commercial Distribution

  • 00630414167459 ()
L2KLH2(D)

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Systems, ACS:180® Systems Calibrator C - 00630414124919

Ferritin/VitB12 - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10311575
In Commercial Distribution

  • 00630414124919 ()
672182000

  • Multiple anaemia-related analyte IVD, calibrator

ADVIA Centaur® Calibrator D - 00630414124797

Calibrator D - 2 pack (AFP Cal; CEA Cal)
Siemens Healthcare Diagnostics Inc.
10311569
In Commercial Distribution

  • 00630414124797 ()
672173000

  • Multiple tissue-associated protein/tumour marker IVD, calibrator

ADVIA Centaur® Calibrator C - 00630414124780

Ferritin/VitB12 - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10311568
In Commercial Distribution

  • 00630414124780 ()
672172000

  • Multiple anaemia-related analyte IVD, calibrator

RAPIDLab® High G/L - 00630414121628

For in vitro diagnostic use for verifying glucose and lactate sensor performance on the RAPIDLab® 1260 & 1265 systems
Siemens Healthcare Diagnostics Inc.
10311387
In Commercial Distribution

  • 00630414121628 ()
  • 00630414024516 ()
570097

  • Multiple blood gas analyte IVD, calibrator

RAPIDLab® Reference Electrode Fill - 00630414117539

RAPIDLab® series Reference Electrode Fill Solution. An in vitro diagnostic medical device for use with RAPIDLab® series analyzers.
Siemens Healthcare Diagnostics Inc.
10311081
In Commercial Distribution

  • 00630414117539 ()
  • 00630414010090 ()
478822

  • Ion selective electrode (ISE) reference solution IVD, reagent

Adapters - 00630414116297

100 Adaptors for an In vitro diagnostics device. For use with Siemens Healthcare Diagnostics blood collection capillary tubes and analyzers.
Siemens Healthcare Diagnostics Inc.
10330785
In Commercial Distribution

  • 00630414116297 ()
  • 00630414010168 ()
478647

  • Capillary blood collection tube IVD, electrolyte-balanced heparin

Blood Gas blood collection capillary tubes - 00630414115856

500 blood collection capillary tubes. Each tube contains 130-200 units/mL Lithium Heparin (approx. volume 140µL)
Siemens Healthcare Diagnostics Inc.
10327012
In Commercial Distribution

  • 00630414115856 ()
  • 00630414009599 ()
478608

  • Capillary blood collection tube IVD, lithium heparin

Capillary Caps - 00630414115801

100 capillary caps. An in vitro diagnostics medical device for use with Siemens Healthcare Diagnostics Multicap® and Multicap-S 2.34mm OD blood collection capillary tubes.
Siemens Healthcare Diagnostics Inc.
10311054
In Commercial Distribution

  • 00630414115801 ()
  • 00630414009292 ()
478605

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
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