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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T3 Total (T3) Atellica IM - RGT 120T
Siemens Healthcare Diagnostics Inc.
10995679
In Commercial Distribution

  • 00630414599922 ()
10995679

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
Multi-Diluent 10 Atellica IM - CONS (2 PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995640
In Commercial Distribution

  • 00630414599588 ()
  • 00630414007656 ()
10995640

  • Buffered sample diluent IVD
Multi-Diluent 1 Atellica IM - CONS (Bottle) 1 x 50mL
Siemens Healthcare Diagnostics Inc.
10995639
In Commercial Distribution

  • 00630414599571 ()
10995639

  • Buffered sample diluent IVD
Multi-Diluent 1 Atellica IM - CONS (6PK) 6 x 25mL
Siemens Healthcare Diagnostics Inc.
10995638
In Commercial Distribution

  • 00630414599564 ()
  • 00630414007649 ()
10995638

  • Buffered sample diluent IVD
Multi-Diluent 1 Atellica IM - CONS (2PK) 2 x 25mL
Siemens Healthcare Diagnostics Inc.
10995637
In Commercial Distribution

  • 00630414599557 ()
  • 00630414007632 ()
10995637

  • Buffered sample diluent IVD
Luteinizing Hormone (LH) Atellica IM - Master Curve Material Kit 10 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995636
In Commercial Distribution

  • 00630414599540 ()
10995636

  • Luteinizing hormone (LH) IVD, control
Luteinizing Hormone (LH) Atellica IM - RGT - 110T
Siemens Healthcare Diagnostics Inc.
10995635
In Commercial Distribution

  • 00630414599533 ()
10995635

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
Luteinizing Hormone (LH) Atellica IM - RGT - 550T
Siemens Healthcare Diagnostics Inc.
10995634
In Commercial Distribution

  • 00630414599526 ()
  • 00630414007625 ()
10995634

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
Intact parathyroid hormone (iPTH) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995626
In Commercial Distribution

  • 00630414599496 ()
10995626

  • Parathyroid hormone (PTH) IVD, control
Intact parathyroid hormone (iPTH) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995625
In Commercial Distribution

  • 00630414599489 ()
10995625

  • Parathyroid hormone (PTH) IVD, control
Intact Parathyroid Hormone (iPTH) Atellica IM - RGT 950T
Siemens Healthcare Diagnostics Inc.
10995622
In Commercial Distribution

  • 00630414599458 ()
10995622

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Intact Parathyroid Hormone (iPTH) Atellica IM - RGT 190T
Siemens Healthcare Diagnostics Inc.
10995621
In Commercial Distribution

  • 00630414599441 ()
10995621

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Total IgE (tIgE) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995617
In Commercial Distribution

  • 00630414599403 ()
10995617

  • Total immunoglobulin E (IgE total) IVD, control
IgE Multi-Diluent Atellica IM - CONS (2PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995616
In Commercial Distribution

  • 00630414599397 ()
  • 00630414007618 ()
10995616

  • Buffered sample diluent IVD
IgE (tIgE) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995615
In Commercial Distribution

  • 00630414599380 ()
10995615

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
IgE (tIgE) Atellica IM – RGT 250T
Siemens Healthcare Diagnostics Inc.
10995614
In Commercial Distribution

  • 00630414599373 ()
  • 00630414007601 ()
10995614

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
HIV 1/O/2 (eHIV) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995611
In Commercial Distribution

  • 00630414599342 ()
10995611

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
Homocysteine (HYC) Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995609
In Commercial Distribution

  • 00630414599328 ()
10995609

  • Homocysteine IVD, control
Homocysteine (HYC) Multi-Diluent Atellica IM - CONS (2PK) 2 x 10mL
Siemens Healthcare Diagnostics Inc.
10995608
In Commercial Distribution

  • 00630414599311 ()
  • 00630414007595 ()
10995608

  • Buffered sample diluent IVD
Homocysteine (HYC) Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995607
In Commercial Distribution

  • 00630414599304 ()
10995607

  • Homocysteine IVD, kit, chemiluminescent immunoassay
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
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