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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TG Ab - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995461
In Commercial Distribution

  • 00630414597881 ()
10995461

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
HCV (aHCV) QC Kit - Atellica IM - CLT 2 x 2 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10995457
In Commercial Distribution

  • 00630414597874 ()
10995457

  • Hepatitis C virus total antibody IVD, control
HCV (aHCV) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995456
In Commercial Distribution

  • 00630414597867 ()
10995456

  • Hepatitis C virus total antibody IVD, kit, chemiluminescent assay
Anti-HBs2 (aHBs2) QC Kit - Atellica IM - CLT 2 x 2 x 10.0 mL
Siemens Healthcare Diagnostics Inc.
10995454
In Commercial Distribution

  • 00630414597843 ()
10995454

  • Hepatitis B virus surface total antibody IVD, control
Anti-HBs2 (aHBs2) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995453
In Commercial Distribution

  • 00630414597836 ()
10995453

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
HBc IgM (aHBcM) QC Kit - Atellica IM - CTL 2 x 2 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10995450
In Commercial Distribution

  • 00630414597805 ()
10995450

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
HBc IgM (aHBcM) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995449
In Commercial Distribution

  • 00630414597799 ()
10995449

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
HAV Total (HAVT) QC Kit - Atellica IM - CTL 2 x 2 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10995447
In Commercial Distribution

  • 00630414597775 ()
10995447

  • Hepatitis A virus total antibody IVD, control
HAV Total Ab (aHAVT) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995596
In Commercial Distribution

  • 00630414597768 ()
10995596

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
HAV IgM Ab (aHAVM) QC Kit Atellica IM - CLT 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10995445
In Commercial Distribution

  • 00630414597744 ()
10995445

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
HAV IgM Ab (aHAVM) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995444
In Commercial Distribution

  • 00630414597737 ()
10995444

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Alpha-Fetoprotein(AFP) - Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995443
In Commercial Distribution

  • 00630414597720 ()
10995443

  • Alpha-fetoprotein (AFP) IVD, control
RBC Folate - Atellica IM - CONS - 4 x 30mL
Siemens Healthcare Diagnostics Inc.
10995440
In Commercial Distribution

  • 00630414597690 ()
  • 00630414190600 ()
10995440

  • Dithiothriotol (DTT) reagent IVD
ß2-Microglobulin (B2M) Calibrator Atellica CH - CAL 3 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099442
In Commercial Distribution

  • 00630414597638 ()
  • 00630414007175 ()
11099442

  • Beta-2-microglobulin IVD, calibrator
Urinary Total Protein (UPro) Calibrator Atellica CH - CAL 3 x 5.0mL
Siemens Healthcare Diagnostics Inc.
11099441
Not in Commercial Distribution

  • 00630414597621 ()
  • 00630414007168 ()
11099441

  • Total protein IVD, calibrator
Toxicology (TOX) Calibrator Atellica CH - CAL 5 x 2 x 2.5mL
Siemens Healthcare Diagnostics Inc.
11099440
In Commercial Distribution

  • 00630414597614 ()
  • 00630414007090 ()
11099440

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
TDM Calibrator Atellica CH - CAL 5 x 2 x 3.0mL
Siemens Healthcare Diagnostics Inc.
11099439
In Commercial Distribution

  • 00630414597607 ()
11099439

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator
Special Chemistry (SPCL) Calibrator Atellica CH - CAL 10 x 5.0mL
Siemens Healthcare Diagnostics Inc.
11099438
In Commercial Distribution

  • 00630414597591 ()
  • 00630414007151 ()
11099438

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Methadone Metabolite (MetMtb) Calibrator Atellica CH - CAL 1 x 10mL
Siemens Healthcare Diagnostics Inc.
11099437
Not in Commercial Distribution

  • 00630414597584 ()
11099437

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator
Microalbumin (µALB_2) Calibrator Atellica CH - CAL 5 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11099435
In Commercial Distribution

  • 00630414597560 ()
11099435

  • Microalbumin IVD, calibrator
Liquid Specific Protein (LSP) Calibrator Atellica CH - CAL 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099434
In Commercial Distribution

  • 00630414597553 ()
11099434

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Lipoprotein a (LP(a)) Calibrator Atellica CH - CAL 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099433
In Commercial Distribution

  • 00630414597546 ()
11099433

  • Lipoprotein A IVD, calibrator
Fructosamine (Fruc) Calibrator Atellica CH - CAL 3 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099432
In Commercial Distribution

  • 00630414597539 ()
  • 00630414007144 ()
11099432

  • Fructosamine IVD, calibrator
Cystatin-C (CysC) Calibrator Atellica™ CH - CAL 5 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11099431
In Commercial Distribution

  • 00630414597522 ()
11099431

  • Cystatin C IVD, calibrator
C-Reative Protein (CRP) Calibrator Atellica CH - CAL 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099430
In Commercial Distribution

  • 00630414597515 ()
11099430

  • C-reactive protein (CRP) IVD, calibrator
High Sensitivity C-Reative Protein (hsCRP) Calibrator Atellica CH - CAS 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099412
In Commercial Distribution

  • 00630414597508 ()
11099412

  • C-reactive protein (CRP) IVD, calibrator
Chemistry Calibrator Atellica CH - CAL 12 x 3.0mL
Siemens Healthcare Diagnostics Inc.
11099411
In Commercial Distribution

  • 00630414597492 ()
  • 00630414007106 ()
11099411

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Atellica CH DRUG CAL II - CAL 5 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
11099405
In Commercial Distribution

  • 00630414597485 ()
  • 00630414211565 ()
11099405

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator
HDL/LDL Cholesterol Calibrator Atellica CH - CAL 3 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099402
Not in Commercial Distribution

  • 00630414597454 ()
  • 00630414007137 ()
11099402

  • Multiple lipid analyte IVD, calibrator
CO2 Calibrator Atellica CH - CAL 2 x 21.0mL
Siemens Healthcare Diagnostics Inc.
11099401
In Commercial Distribution

  • 00630414597447 ()
  • 00630414007113 ()
11099401

  • Carbon dioxide (CO2) IVD, calibrator
Drug Calibrator Atellica CH - CAL 5 x 2 x 3.0mL
Siemens Healthcare Diagnostics Inc.
11099336
In Commercial Distribution

  • 00630414597386 ()
  • 00630414211558 ()
11099336

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator
Chemistry III Calibrator Atellica CH - CAL 3 x 2 x 2.5mL
Siemens Healthcare Diagnostics Inc.
11099335
In Commercial Distribution

  • 00630414597379 ()
  • 00630414211541 ()
11099335

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Apolipoprotein A1 & B Calibrators Atellica CH - CAL 5 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099329
In Commercial Distribution

  • 00630414597317 ()
  • 00630414007120 ()
11099329

  • Multiple apolipoprotein IVD, calibrator
Hemoglobin A1c (A1c_3) Calibrator Atellica CH - CAL 4 x 2 x 0.5mL
Siemens Healthcare Diagnostics Inc.
11099328
Not in Commercial Distribution

  • 00630414597300 ()
  • 00630414211534 ()
11099328

  • Glycated haemoglobin (HbA1c) IVD, calibrator
Enzyme 3 (ENZ 3) Calibrator Atellica CH - CAL 6 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11099319
In Commercial Distribution

  • 00630414597249 ()
  • 00630414007021 ()
11099319

  • Total creatine kinase (CK) IVD, calibrator
Enzyme 2 (ENZ 2) Calibrator Atellica CH - CAL 6 x 1.5mL
Siemens Healthcare Diagnostics Inc.
11099318
In Commercial Distribution

  • 00630414597232 ()
  • 00630414007038 ()
11099318

  • Multiple clinical chemistry enzyme IVD, calibrator
Enzyme 1 (ENZ 1) Calibrator Atellica CH - CAL 6 x 2.5mL
Siemens Healthcare Diagnostics Inc.
11099317
In Commercial Distribution

  • 00630414597225 ()
  • 00630414007014 ()
11099317

  • Multiple clinical chemistry enzyme IVD, calibrator
Alkaline Phosphatase Calibrator (ALP) Atellica CH - CAL 6 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099316
In Commercial Distribution

  • 00630414597218 ()
  • 00630414007045 ()
11099316

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Albumin BCP (AlbP) Calibrator Atellica CH - CAL 3 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11099310
In Commercial Distribution

  • 00630414597201 ()
  • 00630414007052 ()
11099310

  • Albumin IVD, calibrator
ADVIA Centaur® XPT Analyzer
Siemens Healthcare Diagnostics Inc.
10711433
In Commercial Distribution

  • 00630414596914 ()
10711433

  • Chemiluminescent immunoassay analyser IVD
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