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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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Atellica CH ECRE3 - 00630414610948

Enzymatic Creatinine_3 (ECre3) Atellica CH Assay 2000 Tests
Siemens Healthcare Diagnostics Inc.
11537216
In Commercial Distribution

  • 00630414301587 ()
  • 00630414610948 ()
11537216

  • Creatinine IVD, kit, spectrophotometry

Atellica CH Revised C-Reactive Protein (RCRP) - 00630414610887

Atellica CH C-Reactive Protein (RCRP) Reagent
Siemens Healthcare Diagnostics Inc.
11537223
In Commercial Distribution

  • 00630414305127 ()
  • 00630414610887 ()
11537223

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Atellica CH LDLC CAL - 00630414610870

LDL Cholesterol Calibrator Atellica CH - CAL 3 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11537241
In Commercial Distribution

  • 00630414305134 ()
  • 00630414610870 ()
11537241

  • Low density lipoprotein (LDL) cholesterol IVD, calibrator

Atellica CH HDLC CAL - 00630414610863

HDL Cholesterol Calibrator Atellica CH - CAL 3 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11537240
In Commercial Distribution

  • 00630414305165 ()
  • 00630414610863 ()
11537240

  • High density lipoprotein (HDL) cholesterol IVD, calibrator

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)

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
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