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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Homocysteine (HYC) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995606
In Commercial Distribution

  • 00630414599298 ()
10995606

  • Homocysteine IVD, kit, chemiluminescent immunoassay
HBsAgII (HBsII) QC Kit - Atellica IM - CLT 2 x 2 x 15.0mL
Siemens Healthcare Diagnostics Inc.
10995605
In Commercial Distribution

  • 00630414599281 ()
10995605

  • Hepatitis B virus surface antigen IVD, control
HBsAgII (HBsII) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995604
In Commercial Distribution

  • 00630414599274 ()
10995604

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
HBsAg Confirmatory (HBsII Conf) - Atellica IM - RGT - 98T
Siemens Healthcare Diagnostics Inc.
10995603
In Commercial Distribution

  • 00630414599267 ()
10995603

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay
Hepatitis Be Antigen (HBeAg) - Atellica IM - RGT - 50T
Siemens Healthcare Diagnostics Inc.
10995600
In Commercial Distribution

  • 00630414599236 ()
10995600

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
Hepatitis Be Antigen (HBeAg) QC Kit - Atellica IM - CLT 2 x 1 x 15.0mL
Siemens Healthcare Diagnostics Inc.
10995599
In Commercial Distribution

  • 00630414599229 ()
10995599

  • Hepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD, control
HBC Total Ab (HBcT) QC Kit - Atellica IM - CLT 2 x 2 x 15.0mL
Siemens Healthcare Diagnostics Inc.
10995598
In Commercial Distribution

  • 00630414599212 ()
10995598

  • Hepatitis B virus core total antibody IVD, control
HBC Total Ab (HBcT) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995597
In Commercial Distribution

  • 00630414599205 ()
10995597

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
Her-2/neu (H2n) QC Kit Atellica IM - CLT 2 x 2 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995594
In Commercial Distribution

  • 00630414599182 ()
10995594

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control
Her-2/neu (H2n) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995593
In Commercial Distribution

  • 00630414599175 ()
10995593

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control
Her-2/neu (H2n) Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995592
In Commercial Distribution

  • 00630414599168 ()
  • 00630414190952 ()
10995592

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, calibrator
Her-2/neu (H2n) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995591
In Commercial Distribution

  • 00630414599151 ()
10995591

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, chemiluminescent immunoassay
Free T4 (FT4) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995590
In Commercial Distribution

  • 00630414599144 ()
10995590

  • Free thyroxine (FT4) IVD, control
Free T4 (FT4) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995589
In Commercial Distribution

  • 00630414599137 ()
10995589

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Free T4 (FT4) Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995588
In Commercial Distribution

  • 00630414599120 ()
  • 00630414007588 ()
10995588

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Free T3 (FT3) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995586
In Commercial Distribution

  • 00630414599106 ()
10995586

  • Free triiodothyronine (FT3) IVD, control
Free T3 (FT3) Atellica IM - RGT 60T
Siemens Healthcare Diagnostics Inc.
10995585
In Commercial Distribution

  • 00630414599090 ()
10995585

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Folic Acid DTT/REL AGT - Atellica IM - Kit
Siemens Healthcare Diagnostics Inc.
10995576
In Commercial Distribution

  • 00630414599007 ()
10995576

  • Dithiothriotol (DTT) reagent IVD
Folic Acid (Fol) - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995575
In Commercial Distribution

  • 00630414598994 ()
10995575

  • Folate (vitamin B9) IVD, control
Folic Acid Diluent - Atellica IM - CONS - (2 PK) 2 x 10mL
Siemens Healthcare Diagnostics Inc.
10995574
In Commercial Distribution

  • 00630414598987 ()
  • 00630414007526 ()
10995574

  • Buffered sample diluent IVD
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
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