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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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Atellica IM Multi-Diluent 1 - 00630414599564

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

Atellica IM Multi-Diluent 1 - 00630414599557

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

Atellica IM LH MCM - 00630414599540

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

Atellica IM LH - 00630414599533

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

  • 00630414599533 ()
10995635

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

Atellica IM LH - 00630414599526

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

Atellica IM PTH QC - 00630414599496

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

Atellica IM PTH MCM - 00630414599489

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

Atellica IM PTH - 00630414599458

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

Atellica IM PTH - 00630414599441

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

Atellica IM tIgE MCM - 00630414599403

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

Atellica IM tIgE DIL - 00630414599397

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

Atellica IM tIgE - 00630414599380

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

Atellica IM tIgE - 00630414599373

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

Atellica IM EHIV - 00630414599342

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

Atellica IM HCY MCM - 00630414599328

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

Atellica IM HCY DIL - 00630414599311

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

Atellica IM HCY - 00630414599304

Homocysteine (HYC) Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995607
In Commercial Distribution

  • 00630414599304 ()
10995607

  • Homocysteine IVD, kit, chemiluminescent immunoassay

Atellica IM HCY - 00630414599298

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

  • 00630414599298 ()
10995606

  • Homocysteine IVD, kit, chemiluminescent immunoassay

Atellica™ IM HBsII QC - 00630414599281

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

Atellica™ IM HBsII - 00630414599274

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

Atellica™ IM HBsII Confirmatory - 00630414599267

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

Atellica™ IM HBeAg - 00630414599236

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

Atellica™ IM HBeAg QC - 00630414599229

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

Atellica™ IM HBcT QC - 00630414599212

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

Atellica™ IM HBcT - 00630414599205

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

Atellica IM H2n QC - 00630414599182

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

Atellica IM H2n MCM - 00630414599175

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

Atellica IM H2n Calibrator - 00630414599168

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

Atellica IM H2n - 00630414599151

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

Atellica IM FT4 MCM - 00630414599144

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
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