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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TSH3-ULII Atellica IM - Consumable MCM Set
Siemens Healthcare Diagnostics Inc.
11208876
In Commercial Distribution

  • 00630414624532 ()
11208876

  • Thyroid stimulating hormone (TSH) IVD, control
TSH3-ULII Atellica IM – RGT 550T
Siemens Healthcare Diagnostics Inc.
11208707
In Commercial Distribution

  • 00630414624525 ()
11208707

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH3-ULII Atellica IM - RGT 110T
Siemens Healthcare Diagnostics Inc.
11208706
In Commercial Distribution

  • 00630414624518 ()
11208706

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH3-ULII ADVIA Centaur - RGT (REF) 2500T
Siemens Healthcare Diagnostics Inc.
11208703
In Commercial Distribution

  • 00630414624501 ()
11208703

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH3-ULII ADVIA Centaur - RGT 500T
Siemens Healthcare Diagnostics Inc.
11208702
In Commercial Distribution

  • 00630414624488 ()
11208702

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
ATELLICA IM ELF KIT
Siemens Healthcare Diagnostics Inc.
11208118
In Commercial Distribution

  • 00630414618463 ()
11208118

  • Multiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay
ADVIA CENTAUR ELF MCM SET
Siemens Healthcare Diagnostics Inc.
11208709
In Commercial Distribution

  • 00630414618456 ()
11208709

  • Multiple liver fibrosis marker IVD, control
ADVIA CENTAUR ELF KIT
Siemens Healthcare Diagnostics Inc.
11207300
In Commercial Distribution

  • 00630414618128 ()
11207300

  • Multiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay
ATELLICA IM ELF MCM SET
Siemens Healthcare Diagnostics Inc.
11208708
In Commercial Distribution

  • 00630414618111 ()
11208708

  • Multiple liver fibrosis marker IVD, control
Atellica CH Bilirubin Calibrator (BILI CAL)
Siemens Healthcare Diagnostics Inc.
11537243
In Commercial Distribution

  • 00630414313450 ()
  • 00630414615097 ()
11537243

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
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)
Siemens Healthcare Diagnostics Inc.
11537220
In Commercial Distribution

  • 00630414313436 ()
  • 00630414614922 ()
11537220

  • Total bilirubin IVD, kit, spectrophotometry
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 solution
Siemens Healthcare Diagnostics Inc.
11417930
In Commercial Distribution

  • 00630414613437 ()
  • 00630414317014 ()
11417930

  • Chemiluminescent immunoassay signal generation kit IVD
Atellica IM Acid
Siemens Healthcare Diagnostics Inc.
11417929
In Commercial Distribution

  • 00630414613239 ()
  • 00630414317007 ()
11417929

  • Chemiluminescent immunoassay signal generation kit IVD
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 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 (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 (TP_2)
Siemens Healthcare Diagnostics Inc.
11537228
In Commercial Distribution

  • 00630414306025 ()
  • 00630414611082 ()
11537228

  • Total protein IVD, kit, spectrophotometry
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
Cholinestrase (CHE_2) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537221
In Commercial Distribution

  • 00630414305042 ()
  • 00630414611044 ()
11537221

  • Pseudocholinesterase IVD, kit, spectrophotometry
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
Haptoglobin (HAPT2) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537232
In Commercial Distribution

  • 00630414305080 ()
  • 00630414610986 ()
11537232

  • Haptoglobin IVD, kit, nephelometry/turbidimetry
Lactate_3 (LAC_3) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537218
In Commercial Distribution

  • 00630414305066 ()
  • 00630414610979 ()
11537218

  • Lactate IVD, kit, spectrophotometry
Creatinine enzymatic - ADVIA Chem. - RGT
Siemens Healthcare Diagnostics Inc.
11537235
In Commercial Distribution

  • 00630414306438 ()
  • 00630414610962 ()
11537235

  • Creatinine IVD, kit, spectrophotometry
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 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
Siemens Healthcare Diagnostics Inc.
11417771
Not in Commercial Distribution

  • 00630414298382 ()
  • 00630414607139 ()
K7771

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
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
Siemens Healthcare Diagnostics Inc.
11417414
Not in Commercial Distribution

  • 00630414297613 ()
  • 00630414605500 ()
K7414

  • SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
DV/DM COV2T/CV2T CAL
Siemens Healthcare Diagnostics Inc.
11417413
Not in Commercial Distribution

  • 00630414297606 ()
  • 00630414605494 ()
KC813

  • SARS-CoV-2 total antibody IVD, calibrator
DV/DM COV2T/CV2T POS/NEG CTRL
Siemens Healthcare Diagnostics Inc.
11417415
Not in Commercial Distribution

  • 00630414297620 ()
  • 00630414605425 ()
KC815

  • SARS-CoV-2 total antibody IVD, control
Dimension CV2T Assay
Siemens Healthcare Diagnostics Inc.
11417412
Not in Commercial Distribution

  • 00630414297590 ()
  • 00630414605418 ()
RF812

  • SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
Atellica CH EMPTY1
Siemens Healthcare Diagnostics Inc.
11538114
In Commercial Distribution

  • 00630414297651 ()
  • 00630414604664 ()
11538114

  • General laboratory assay tray
Atellica CH EMPTY2
Siemens Healthcare Diagnostics Inc.
11538115
In Commercial Distribution

  • 00630414297682 ()
  • 00630414604503 ()
11538115

  • General laboratory assay tray
Androstenedione (Andro) ADVIA Centaur - RGT 50T
Siemens Healthcare Diagnostics Inc.
10997290
In Commercial Distribution

  • 00630414603445 ()
10997290

  • Androstenedione IVD, kit, chemiluminescent immunoassay
Androstenedione (Andro) ADVIA Centaur - Master Curve Material 5x1x1.0mL
Siemens Healthcare Diagnostics Inc.
10997268
In Commercial Distribution

  • 00630414603438 ()
10997268

  • Androstenedione IVD, control
ADVIA Centaur Sex Hormone Binding Globulin Master Curve Material (SHBG MCM) Set - 5x1mL - 5 Levels
Siemens Healthcare Diagnostics Inc.
10997193
In Commercial Distribution

  • 00630414603414 ()
10997193

  • Sex hormone binding globulin (SHBG) IVD, control
ADVIA Centaur Sex Hormone Binding Globulin Calibrator (SHBG CAL) Set - 2x2x2mL - 2PK
Siemens Healthcare Diagnostics Inc.
10997192
In Commercial Distribution

  • 00630414603407 ()
10997192

  • Sex hormone binding globulin (SHBG) IVD, calibrator
ADVIA Centaur Sex Hormone Binding Globulin (SHBG) - 50 tests - 1PK
Siemens Healthcare Diagnostics Inc.
10997191
In Commercial Distribution

  • 00630414603391 ()
10997191

  • Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay
Active B12 Control Set - CENTAUR - CTL - 1x2x7mL
Siemens Healthcare Diagnostics Inc.
10995091
In Commercial Distribution

  • 00630414603124 ()
10995091

  • Holotranscobalamin (holoTC) IVD, control
Active B12 - CENTAUR - MCM
Siemens Healthcare Diagnostics Inc.
10995090
In Commercial Distribution

  • 00630414603117 ()
10995090

  • Holotranscobalamin (holoTC) IVD, control
Active B12 - RGT - CENTAUR - 100T
Siemens Healthcare Diagnostics Inc.
10995088
In Commercial Distribution

  • 00630414603100 ()
10995088

  • Holotranscobalamin (holoTC) IVD, kit, chemiluminescent immunoassay
ADVIA Centaur T3 Master Curve Material (MCM) - 7x 1mL - 7 levels
Siemens Healthcare Diagnostics Inc.
10996931
In Commercial Distribution

  • 00630414603094 ()
10996931

  • Total triiodothyronine (TT3) IVD, control
Progesterone Master Curve Material SET - CENTAUR – CONS
Siemens Healthcare Diagnostics Inc.
10996673
In Commercial Distribution

  • 00630414603070 ()
10996673

  • Progesterone IVD, control
ADVIA Centaur FSH Master Curve Material (MCM) - 8x1mL - 8 levels
Siemens Healthcare Diagnostics Inc.
10996671
In Commercial Distribution

  • 00630414603063 ()
10996671

  • Follicle stimulating hormone (FSH) IVD, control
Cortisol - RGT - CENTAUR - 250T
Siemens Healthcare Diagnostics Inc.
10994926
In Commercial Distribution

  • 00630414602950 ()
  • 00630414006192 ()
10994926

  • Total cortisol IVD, kit, chemiluminescent immunoassay
Cortisol - RGT - CENTAUR - 50T
Siemens Healthcare Diagnostics Inc.
10994924
In Commercial Distribution

  • 00630414602943 ()
10994924

  • Total cortisol IVD, kit, chemiluminescent immunoassay
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
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