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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Zika IgM ADVIA Centaur Quality Control Material Kit 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11202472
In Commercial Distribution

  • 00630414247014 ()
11202472

  • Zika virus immunoglobulin M (IgM) antibody IVD, control
Zika IgM ADVIA Centaur Assay Kit 50T
Siemens Healthcare Diagnostics Inc.
11202471
In Commercial Distribution

  • 00630414247007 ()
11202471

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
CMV IgG Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11202208
In Commercial Distribution

  • 00630414246635 ()
11202208

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Procalcitonin (PCT) QC Kit Atellica IM - CLT 2 x 2 x 2.0mL/vial
Siemens Healthcare Diagnostics Inc.
11202700
In Commercial Distribution

  • 00630414246567 ()
  • 00630414246581 ()
11202700

  • Procalcitonin (PCT) IVD, control
Procalcitonin (PCT) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11202699
In Commercial Distribution

  • 00630414246550 ()
11202699

  • Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay
CMV IgG Atellica IM - Quality Control
Siemens Healthcare Diagnostics Inc.
11202209
In Commercial Distribution

  • 00630414246482 ()
  • 00630414283920 ()
11202209

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control
Erythropoietin (EPO) QC Kit - Atellica IM - CLT 3 x 3 x 7.0mL
Siemens Healthcare Diagnostics Inc.
10733008
In Commercial Distribution

  • 00630414245799 ()
10733008

  • Erythropoietin (EPO) IVD, control
Erythropoietin (EPO) - Atellica IM - Master Curve Material Kit 5 x 1 x 1mL
Siemens Healthcare Diagnostics Inc.
10733007
In Commercial Distribution

  • 00630414245782 ()
10733007

  • Erythropoietin (EPO) IVD, control
Erythropoietin (EPO) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10733006
In Commercial Distribution

  • 00630414245775 ()
10733006

  • Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay
Calcitonin (CALCT) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10733005
In Commercial Distribution

  • 00630414245768 ()
10733005

  • Calcitonin IVD, control
Active-B12 (AB12) Atellica IM - Master Curve Material Kit 5 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10733003
In Commercial Distribution

  • 00630414245744 ()
10733003

  • Holotranscobalamin (holoTC) IVD, control
Active-B12 (AB12) QC Kit Atellica IM - CLT 2 x 1 x 7.0mL
Siemens Healthcare Diagnostics Inc.
10733002
In Commercial Distribution

  • 00630414245737 ()
10733002

  • Holotranscobalamin (holoTC) IVD, control
Active-B12 (AB12) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10733001
In Commercial Distribution

  • 00630414245720 ()
10733001

  • Holotranscobalamin (holoTC) IVD, kit, chemiluminescent immunoassay
anti-CCP IgG (aCCP) Atellica IM - Master Curve Material 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10733000
In Commercial Distribution

  • 00630414245683 ()
10733000

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control
anti-CCP IgG (aCCP) QC Kit Atellica IM - CLT 2 x 1 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10732999
In Commercial Distribution

  • 00630414245676 ()
10732999

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control
anti-CCP IgG (aCCP) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10732998
In Commercial Distribution

  • 00630414245669 ()
10732998

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay
Vista T4/TU CAL
Siemens Healthcare Diagnostics Inc.
11319105
In Commercial Distribution

  • 00630414240268 ()
KC165

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Alpha-Fetoprotein(AFP) - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
11202258
In Commercial Distribution

  • 00630414238807 ()
11202258

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Alpha-Fetoprotein(AFP) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11202257
In Commercial Distribution

  • 00630414238791 ()
11202257

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Procalcitonin (PCT) DM EXL LOCI BRAHMS - Cal Kit
Siemens Healthcare Diagnostics Inc.
11354448
In Commercial Distribution

  • 00630414295039 ()
  • 00630414238708 ()
RC648

  • Procalcitonin (PCT) IVD, calibrator
Procalcitonin (PCT) DM EXL LOCI BRAHMS - RGT
Siemens Healthcare Diagnostics Inc.
11354447
In Commercial Distribution

  • 00630414298214 ()
  • 00630414238692 ()
RF648

  • Procalcitonin (PCT) IVD, reagent
Amylase_2 (AMY_2) Atellica CH - RGT 1050T
Siemens Healthcare Diagnostics Inc.
11097649
In Commercial Distribution

  • 00630414238357 ()
11097649

  • Total amylase IVD, kit, spectrophotometry
Tacrolimus (TACR) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097542
In Commercial Distribution

  • 00630414238340 ()
11097542

  • Tacrolimus therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Siemens Healthcare Diagnostics Inc.
10736583
In Commercial Distribution

  • 00630414238142 ()
10736583

  • Medical equipment clinical data interfacing software
Cystatin C_2 (CYSC_2) Calibrators Atellica CH - CAL 5 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11097648
In Commercial Distribution

  • 00630414238104 ()
11097648

  • Cystatin C IVD, calibrator
Oxycodone (OXY) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097541
In Commercial Distribution

  • 00630414238098 ()
11097541

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)
ADVIA 2120i Refurbished System, Without Autosampler
Siemens Healthcare Diagnostics Inc.
11314046
In Commercial Distribution

  • 00630414237909 ()
11314046

  • Haematological cell analyser IVD
ADVIA 2120i Refurbished System, Dual Aspirate
Siemens Healthcare Diagnostics Inc.
11314045
In Commercial Distribution

  • 00630414237886 ()
11314045

  • Haematological cell analyser IVD
ADVIA 2120i Refurbished System, Single Aspirate
Siemens Healthcare Diagnostics Inc.
11314044
In Commercial Distribution

  • 00630414237879 ()
11314044

  • Haematological cell analyser IVD
Atellica IM Multi-Diluent 15
Siemens Healthcare Diagnostics Inc.
11200798
In Commercial Distribution

  • 00630414246826 ()
  • 00630414237701 ()
11200798

  • Buffered sample diluent IVD
Cystatin C_2 (CYSC_2) Atellica CH - RGT 800T
Siemens Healthcare Diagnostics Inc.
11097647
In Commercial Distribution

  • 00630414236919 ()
11097647

  • Cystatin C IVD, kit, nephelometry/turbidimetry
ADVIA Centaur® Testosterone (TSTO) Assay Kit 50T
Siemens Healthcare Diagnostics Inc.
11201912
Not in Commercial Distribution

  • 00630414235271 ()
11201912

  • Total testosterone IVD, kit, chemiluminescent immunoassay
Dimension Vista ECREA CAL
Siemens Healthcare Diagnostics Inc.
11349584
In Commercial Distribution

  • 00630414235103 ()
KC270A

  • Creatinine IVD, calibrator
Dimension Vista CHEM 1 CAL
Siemens Healthcare Diagnostics Inc.
11349583
In Commercial Distribution

  • 00630414235097 ()
KC110C

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
11201773
In Commercial Distribution

  • 00630414234489 ()
11201773

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11201772
In Commercial Distribution

  • 00630414234472 ()
11201772

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
Syva Emit II Plus 6-Acetylmorphine Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10730975
In Commercial Distribution

  • 00630414229591 ()
9R029UL

  • 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)
Atellica CI Rack Handler
Siemens Healthcare Diagnostics Inc.
10947348
In Commercial Distribution

  • 00630414229560 ()
10947348

  • Specimen processing instrument IVD
Atellica CI Analyzer
Siemens Healthcare Diagnostics Inc.
10947347
In Commercial Distribution

  • 00630414229553 ()
10947347

  • Multiple clinical chemistry analyser IVD, laboratory
Setpoint CO2 - ADVIA Chem. - CAL - 2x21mL
Siemens Healthcare Diagnostics Inc.
10326423
In Commercial Distribution

  • 00630414227887 ()
  • 00630414003603 ()
T23-1291-52

  • Carbon dioxide (CO2) IVD, calibrator
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