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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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ADVIA Centaur TNIH 100T Kit - 00630414602912

ADVIA Centaur High Sensitivity Troponin I (TNIH) Assay Kit 100T
Siemens Healthcare Diagnostics Inc.
10994774
In Commercial Distribution

  • 00630414602912 ()
10994774

  • Troponin I IVD, kit, chemiluminescent immunoassay

VERSANT HCV 2.0 LiPA - 00630414602882

HCV Genotype
Siemens Healthcare Diagnostics Inc.
10492005
In Commercial Distribution

  • 00630414602882 ()
10492005

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

VERSANT HCV 2.0 LiPA - 00630414602875

HCV genotype
Siemens Healthcare Diagnostics Inc.
10492004
In Commercial Distribution

  • 00630414602875 ()
10492004

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

ADVIA Centaur® VitD MCM - 00630414602721

Vitamin D Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10699746
In Commercial Distribution

  • 00630414602721 ()
10699746

  • Multiple form 25-hydroxy Vitamin D IVD, control

CLINITEK Novus® 10 Urinalysis Cassette 450 - 00630414602653

Cassette to be used on the CLINITEK Novus system for determination of 10 parameters. 450 tests guaranteed per cassette
Siemens Healthcare Diagnostics Inc.
10634643
In Commercial Distribution

  • 00630414602653 ()
10634643

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

ADVIA® 560 5P Diff 1L - 00630414601885

ADVIA® 560 5P Diff 1L
Siemens Healthcare Diagnostics Inc.
11170847
In Commercial Distribution

  • 00630414601885 ()
D3021

  • White blood cell count IVD, kit, cell count

ADVIA® 560 Lyse - 00630414601878

ADVIA® 560 Lyse
Siemens Healthcare Diagnostics Inc.
11170846
In Commercial Distribution

  • 00630414601878 ()
D3015

  • Blood cell lysis reagent IVD

ADVIA® 560 Hematology System Auto-loader - 00630414601823

ADVIA® Autoloader
Siemens Healthcare Diagnostics Inc.
11170843
In Commercial Distribution

  • 00630414601823 ()
AS-SIE

  • Specimen processing instrument IVD

ADVIA® 560 Hematology System - 00630414601816

ADVIA® 560 Hematology System
Siemens Healthcare Diagnostics Inc.
11170842
In Commercial Distribution

  • 00630414601816 ()
A5-SIE

  • Haematological cell analyser IVD

ADVIA® 360/560 Hypoclean 100 mL - 00630414601311

ADVIA® 360/560 Hypoclean 100ml
Siemens Healthcare Diagnostics Inc.
11170851
In Commercial Distribution

  • 00630414601311 ()
D8011

  • Wash/cleaning solution IVD, automated/semi-automated system
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