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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 Prealbumin (PALB) - 00630414614939

Atellica CH Prealbumin (PALB)
Siemens Healthcare Diagnostics Inc.
11537217
In Commercial Distribution

  • 00630414313412 ()
  • 00630414614939 ()
11537217

  • Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry

Atellica CH Diazo Total Bilirubin (D_TBil) - 00630414614922

Atellica CH Diazo Total Bilirubin (D_TBil)
Siemens Healthcare Diagnostics Inc.
11537220
In Commercial Distribution

  • 00630414313436 ()
  • 00630414614922 ()
11537220

  • Total bilirubin IVD, kit, spectrophotometry

Atellica CH Diazo Direct Bilirubin (D_DBil) - 00630414614755

Atellica CH Diazo Direct Bilirubin (D_TBil)
Siemens Healthcare Diagnostics Inc.
11537219
In Commercial Distribution

  • 00630414313429 ()
  • 00630414614755 ()
11537219

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry

Atellica IM Base - 00630414613437

Atellica IM Base solution
Siemens Healthcare Diagnostics Inc.
11417930
In Commercial Distribution

  • 00630414613437 ()
  • 00630414317014 ()
11417930

  • Chemiluminescent immunoassay signal generation kit IVD

Atellica IM Acid - 00630414613239

Atellica IM Acid
Siemens Healthcare Diagnostics Inc.
11417929
In Commercial Distribution

  • 00630414613239 ()
  • 00630414317007 ()
11417929

  • Chemiluminescent immunoassay signal generation kit IVD

A-LYTE IMT Cleaner - 00630414611617

A-LYTE IMT Cleaner
Siemens Healthcare Diagnostics Inc.
11556782
In Commercial Distribution

  • 00630414302751 ()
  • 00630414611617 ()
11556782

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

Atellica CH RCRP Cal - 00630414611297

Atellica CH C-Reactive Protein Calibrator (RCRP CAL)
Siemens Healthcare Diagnostics Inc.
11537245
In Commercial Distribution

  • 00630414305141 ()
  • 00630414611297 ()
11537245

  • C-reactive protein (CRP) IVD, calibrator

Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) - 00630414611112

Atellica CH High Sensitivity C-Reactive Protein (hCRP2) Reagent
Siemens Healthcare Diagnostics Inc.
11537224
In Commercial Distribution

  • 00630414305028 ()
  • 00630414611112 ()
11537224

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

Atellica CH Total Protein_2 - 00630414611082

Atellica CH Total Protein (TP_2)
Siemens Healthcare Diagnostics Inc.
11537228
In Commercial Distribution

  • 00630414306025 ()
  • 00630414611082 ()
11537228

  • Total protein IVD, kit, spectrophotometry

Atellica CH Prot2 CAL - 00630414611051

For the calibration of ASO_3 and hsCRP2 methods on the Atellica CH System
Siemens Healthcare Diagnostics Inc.
11537246
In Commercial Distribution

  • 00630414304915 ()
  • 00630414611051 ()
11537246

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Atellica CH Cholinesterase_2 - 00630414611044

Cholinestrase (CHE_2) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537221
In Commercial Distribution

  • 00630414305042 ()
  • 00630414611044 ()
11537221

  • Pseudocholinesterase IVD, kit, spectrophotometry

Atellica CH LDLC - 00630414611037

LDL Cholesterol (LDLC) Atellica CH Assay 1600 Tests
Siemens Healthcare Diagnostics Inc.
11537214
In Commercial Distribution

  • 00630414305073 ()
  • 00630414611037 ()
11537214

  • Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry

Atellica CH HAPT2 - 00630414610986

Haptoglobin (HAPT2) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537232
In Commercial Distribution

  • 00630414305080 ()
  • 00630414610986 ()
11537232

  • Haptoglobin IVD, kit, nephelometry/turbidimetry

Atellica CH Lactate_3 - 00630414610979

Lactate_3 (LAC_3) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537218
In Commercial Distribution

  • 00630414305066 ()
  • 00630414610979 ()
11537218

  • Lactate IVD, kit, spectrophotometry

ADVIA CHEM Ecre3 - 00630414610962

Creatinine enzymatic - ADVIA Chem. - RGT
Siemens Healthcare Diagnostics Inc.
11537235
In Commercial Distribution

  • 00630414306438 ()
  • 00630414610962 ()
11537235

  • Creatinine IVD, kit, spectrophotometry

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

Vista COV2G Assay - 00630414607139

Vista COV2G Assay
Siemens Healthcare Diagnostics Inc.
11417771
Not in Commercial Distribution

  • 00630414298382 ()
  • 00630414607139 ()
K7771

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Dimension CV2GAssay - 00630414607030

Dimension CV2G Assay
Siemens Healthcare Diagnostics Inc.
11417770
Not in Commercial Distribution

  • 00630414298375 ()
  • 00630414607030 ()
RF870

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Vista COV2T Assay - 00630414605500

Vista COV2T Assay
Siemens Healthcare Diagnostics Inc.
11417414
Not in Commercial Distribution

  • 00630414297613 ()
  • 00630414605500 ()
K7414

  • SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
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