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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 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

Atellica IM FT4 - 00630414599137

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

  • 00630414599137 ()
10995589

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

Atellica IM FT4 - 00630414599120

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

Atellica IM FT3 MCM - 00630414599106

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

Atellica IM FT3 - 00630414599090

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

  • 00630414599090 ()
10995585

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay

Atellica IM FT3 - 00630414599083

Free T3 (FT3) Atellica IM - RGT 300T
Siemens Healthcare Diagnostics Inc.
10995584
In Commercial Distribution

  • 00630414599083 ()
  • 00630414007564 ()
10995584

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay

Atellica IM FSH MCM - 00630414599069

Follicle Stimulating Hormone (FSH) Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995582
In Commercial Distribution

  • 00630414599069 ()
10995582

  • Follicle stimulating hormone (FSH) IVD, control

Atellica IM FSH - 00630414599052

Follicle Stimulating Hormone (FSH) Atellica IM - RGT 950T
Siemens Healthcare Diagnostics Inc.
10995581
In Commercial Distribution

  • 00630414599052 ()
  • 00630414007557 ()
10995581

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

Atellica IM FSH - 00630414599045

Follicle Stimulating Hormone (FSH) Atellica IM - RGT 190T
Siemens Healthcare Diagnostics Inc.
10995580
In Commercial Distribution

  • 00630414599045 ()
10995580

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

Atellica™ IM Fol DTT/Releasing Agent - 00630414599007

Folic Acid DTT/REL AGT - Atellica IM - Kit
Siemens Healthcare Diagnostics Inc.
10995576
In Commercial Distribution

  • 00630414599007 ()
10995576

  • Dithiothriotol (DTT) reagent IVD

Atellica™ IM Fol MCM - 00630414598994

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

Atellica™ IM Fol DIL - 00630414598987

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

Atellica™ IM Fol - 00630414598970

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

  • 00630414598970 ()
10995573

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay

Atellica™ IM Fol - 00630414598963

Folic Acid (Fol) - Atellica IM - RGT - 140T
Siemens Healthcare Diagnostics Inc.
10995572
In Commercial Distribution

  • 00630414598963 ()
10995572

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay

Atellica IM Fer MCM - 00630414598949

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

Atellica IM Fer - 00630414598932

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

  • 00630414598932 ()
10995569

  • Ferritin IVD, kit, chemiluminescent immunoassay

Atellica IM Fer - 00630414598925

Ferritin (Fer) Atellica IM - RGT 450T
Siemens Healthcare Diagnostics Inc.
10995568
In Commercial Distribution

  • 00630414598925 ()
  • 00630414007519 ()
10995568

  • Ferritin IVD, kit, chemiluminescent immunoassay

Atellica IM eE2 MCM - 00630414598888

Enhanced Estradiol (eE2) Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995564
In Commercial Distribution

  • 00630414598888 ()
10995564

  • Estradiol (oestradiol) (E2) IVD, control

Atellica IM eE2 DIL - 00630414598871

Enhanced Estradiol (eE2) Diluent Atellica IM - CONS (2PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995563
In Commercial Distribution

  • 00630414598871 ()
  • 00630414007502 ()
10995563

  • Buffered sample diluent IVD

Atellica IM eE2 - 00630414598864

Estradiol (eE2) Atellica IM RGT - 500T
Siemens Healthcare Diagnostics Inc.
10995562
In Commercial Distribution

  • 00630414598864 ()
10995562

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay

Atellica IM eE2 - 00630414598857

Estradiol (eE2) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995561
In Commercial Distribution

  • 00630414598857 ()
10995561

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay

Atellica IM Dig MCM - 00630414598833

Digoxin (Dig) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995559
In Commercial Distribution

  • 00630414598833 ()
10995559

  • Digoxin therapeutic drug monitoring IVD, control

Atellica IM Dig - 00630414598826

Digoxin (Dig) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995558
In Commercial Distribution

  • 00630414598826 ()
10995558

  • Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay

Atellica IM Dig - 00630414598819

Digoxin (Dig) Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995557
In Commercial Distribution

  • 00630414598819 ()
  • 00630414007496 ()
10995557

  • Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay

Atellica IM DHEAS MCM - 00630414598802

DHEAS - Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995556
In Commercial Distribution

  • 00630414598802 ()
10995556

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control

Atellica IM DHEAS - 00630414598796

DHEAS - Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995555
In Commercial Distribution

  • 00630414598796 ()
10995555

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay

Atellica IM Dgtn - 00630414598789

Digitoxin (Dgtn) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995554
Not in Commercial Distribution

  • 00630414598789 ()
10995554

  • Digitoxin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

Atellica IM Dgtn - 00630414598772

Digitoxin (Dgtn) Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995553
Not in Commercial Distribution

  • 00630414598772 ()
  • 00630414007489 ()
10995553

  • Digitoxin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

Atellica IM CsA PRE Pretreatment - 00630414598765

Cyclosporine (CsA) Pretreatment Atellica IM - CONS (2PK) 2 x 26mL
Siemens Healthcare Diagnostics Inc.
10995552
In Commercial Distribution

  • 00630414598765 ()
  • 00630414007465 ()
10995552

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent

Atellica IM CsA MCM - 00630414598758

Cyclosporine (CsA) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995551
In Commercial Distribution

  • 00630414598758 ()
10995551

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control

Atellica IM Multi-Diluent 12 - 00630414598741

Cyclosporine (CsA) Multi-Diluent Atellica IM - CONS 1 x 20mL
Siemens Healthcare Diagnostics Inc.
10995550
In Commercial Distribution

  • 00630414598741 ()
10995550

  • Buffered sample diluent IVD
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