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 Class Implantable

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ADVIA Centaur TNIH Master Curve Material Kit 5 x 1.0 mL
Siemens Healthcare Diagnostics Inc.
10994776
In Commercial Distribution

  • 00630414602936 ()
10994776

  • Troponin I IVD, control
ADVIA Centaur High Sensitivity Troponin I (TNIH) Assay Kit 500T
Siemens Healthcare Diagnostics Inc.
10994775
In Commercial Distribution

  • 00630414602929 ()
10994775

  • Troponin I IVD, kit, chemiluminescent immunoassay
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
HCV Genotype
Siemens Healthcare Diagnostics Inc.
10492005
In Commercial Distribution

  • 00630414602882 ()
10492005

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
HCV genotype
Siemens Healthcare Diagnostics Inc.
10492004
In Commercial Distribution

  • 00630414602875 ()
10492004

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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
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
Siemens Healthcare Diagnostics Inc.
11170847
In Commercial Distribution

  • 00630414601885 ()
D3021

  • White blood cell count IVD, kit, cell count
ADVIA® 560 Lyse
Siemens Healthcare Diagnostics Inc.
11170846
In Commercial Distribution

  • 00630414601878 ()
D3015

  • Blood cell lysis reagent IVD
ADVIA® Autoloader
Siemens Healthcare Diagnostics Inc.
11170843
In Commercial Distribution

  • 00630414601823 ()
AS-SIE

  • Specimen processing instrument IVD
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