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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Folic Acid (Fol) - Atellica IM - RGT - 700T
Siemens Healthcare Diagnostics Inc.
10995573
In Commercial Distribution

  • 00630414598970 ()
10995573

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
Folic Acid (Fol) - Atellica IM - RGT - 140T
Siemens Healthcare Diagnostics Inc.
10995572
In Commercial Distribution

  • 00630414598963 ()
10995572

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
Ferritin (Fer) Atellica IM - Master Curve Material Kit 8 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995570
In Commercial Distribution

  • 00630414598949 ()
10995570

  • Ferritin IVD, control
Ferritin (Fer) Atellica IM - RGT 90T
Siemens Healthcare Diagnostics Inc.
10995569
In Commercial Distribution

  • 00630414598932 ()
10995569

  • Ferritin IVD, kit, chemiluminescent immunoassay
Calibrator Z - Atellica IM - CAL (2PK) 2 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995521
Not in Commercial Distribution

  • 00630414598482 ()
  • 00630414190921 ()
10995521

  • Digitoxin therapeutic drug monitoring IVD, calibrator
Calibrator Y - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995520
In Commercial Distribution

  • 00630414598475 ()
  • 00630414190914 ()
10995520

  • Complexed prostate specific antigen (cPSA) IVD, calibrator
Calibrator U - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995519
In Commercial Distribution

  • 00630414598468 ()
  • 00630414190907 ()
10995519

  • Myoglobin IVD, calibrator
Calibrator Q - Atellica IM - CAL (6PK) 6 x 2 x 2 mL
Siemens Healthcare Diagnostics Inc.
10995518
In Commercial Distribution

  • 00630414598451 ()
  • 00630414190891 ()
10995518

  • Total prostate specific antigen (tPSA) IVD, calibrator
Calibrator Q Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995517
In Commercial Distribution

  • 00630414598444 ()
  • 00630414190884 ()
10995517

  • Total prostate specific antigen (tPSA) IVD, calibrator
Calibrator O Atellica IM - CAL (2PK) 2 x 2 x 1.0 mL
Siemens Healthcare Diagnostics Inc.
10995516
In Commercial Distribution

  • 00630414598437 ()
  • 00630414190877 ()
10995516

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, calibrator
BR Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995515
In Commercial Distribution

  • 00630414598420 ()
  • 00630414190846 ()
10995515

  • Cancer antigen 27-29 (CA27-29) IVD, calibrator
Calibrator E - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995513
In Commercial Distribution

  • 00630414598406 ()
  • 00630414190839 ()
10995513

  • Multiple steroid hormone IVD, calibrator
Calibrator E Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995512
In Commercial Distribution

  • 00630414598390 ()
  • 00630414190822 ()
10995512

  • Multiple steroid hormone IVD, calibrator
Calibrator D - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995510
In Commercial Distribution

  • 00630414598376 ()
  • 00630414190815 ()
10995510

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
Calibrator D - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995509
In Commercial Distribution

  • 00630414598369 ()
  • 00630414190808 ()
10995509

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
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
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