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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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ADVIA Centaur® aCCP IgG MCM - 00630414592305

Anti-CCP IgG (aCCP) MCM
Siemens Healthcare Diagnostics Inc.
10699140
In Commercial Distribution

  • 00630414592305 ()
10699140

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control

ADVIA Centaur® aHBs2 - 00630414591407

Anti-HBs2 (aHBs2) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10698706
In Commercial Distribution

  • 00630414591407 ()
10698706

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® HBeAg - 00630414591315

Hepatitis B e Antigen (HBeAg) Assay Kit (1-pack) 50T
Siemens Healthcare Diagnostics Inc.
10698639
In Commercial Distribution

  • 00630414591315 ()
10698639

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® PTH - 00630414591278

Intact parathyroid hormone Master Curve Material (iPTH MCM) Set - 7x1 mL - 7 Levels.
Siemens Healthcare Diagnostics Inc.
10698597
In Commercial Distribution

  • 00630414591278 ()
10698597

  • Parathyroid hormone (PTH) IVD, control

ADVIA Centaur® TSTII - 00630414591155

Testosterone II (TSTII) - ADVIA Centaur® - RGT (REF) – 500T
Siemens Healthcare Diagnostics Inc.
10696864
In Commercial Distribution

  • 00630414591155 ()
10696864

  • Total testosterone IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® TST II - 00630414591148

Testosterone II - RGT - CENTAUR - 500 tests
Siemens Healthcare Diagnostics Inc.
10696863
In Commercial Distribution

  • 00630414591148 ()
10696863

  • Total testosterone IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® TST II - 00630414591131

Testosterone II - RGT -100 Tests
Siemens Healthcare Diagnostics Inc.
10696862
In Commercial Distribution

  • 00630414591131 ()
10696862

  • Total testosterone IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® eE2 - 00630414591056

Estradiol - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10697757
In Commercial Distribution

  • 00630414591056 ()
10697757

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

ADVIA Centaur® Calibrator 30 - 00630414591049

ADVIA Centaur® Calibrator 30 (2-pack)
Siemens Healthcare Diagnostics Inc.
10697756
In Commercial Distribution

  • 00630414591049 ()
10697756

  • Multiple steroid hormone IVD, calibrator

Clinitek Novus® Cal 1-4 kit - 00630414590950

Clinitek Novus® calibration kit for use with CLINITEK Novus® automated urine chemistry system
Siemens Healthcare Diagnostics Inc.
10697753
In Commercial Distribution

  • 00630414590950 ()
10697753

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, calibrator

Clinitek Novus® Rinse Additive - 00630414590936

Rinse additive for CLINITEK Novus® automated urine chemistry system.
Siemens Healthcare Diagnostics Inc.
10697754
In Commercial Distribution

  • 00630414590936 ()
  • 00630414010007 ()
10697754

  • Buffered wash solution IVD

ADVIA® Chemistry TRIG_c Reagent - 00630414590394

Triglyceride - ADVIA Chem. - Conc. RGT - 4x1063/4x971 tests
Siemens Healthcare Diagnostics Inc.
10697575
In Commercial Distribution

  • 00630414590394 ()
  • 00630414005966 ()
10697575

  • Triglyceride IVD, kit, spectrophotometry

ADVIA Centaur® CHIV QC - 00630414590202

ADVIA Centaur® CHIV Quality Control Material
Siemens Healthcare Diagnostics Inc.
10697214
In Commercial Distribution

  • 00630414590202 ()
10697214

  • HIV1/HIV2 antigen/antibody IVD, control

ADVIA® Chemistry FRT Ferritin Reagents - 00630414590189

Ferritin - ADVIA Chem. - RGT - 4x200 tests
Siemens Healthcare Diagnostics Inc.
10361938
In Commercial Distribution

  • 00630414590189 ()
4862277

  • Ferritin IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry B2M ß2-Microglobulin Reagents - 00630414590165

b2 Microglobulin - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10361937
Not in Commercial Distribution

  • 00630414590165 ()
4862161

  • Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry AAG a1-Acid Glycoprotein Reagents - 00630414590158

a1 Acid Glycoprotein - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10361936
Not in Commercial Distribution

  • 00630414590158 ()
4862129

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry

RAPIDPoint® 500 Measurement Cartridge - 00630414589770

RAPIDPoint® 500 Measurement Cartridge (750 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Lac, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 500 analyzer.
Siemens Healthcare Diagnostics Inc.
10491449
In Commercial Distribution

  • 00630414589770 ()
10491449

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

RAPIDPoint® 500 Measurement Cartridge - 00630414589763

RAPIDPoint® 500 Measurement Cartridge (400 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Lac, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 500 analyzer.
Siemens Healthcare Diagnostics Inc.
10491448
In Commercial Distribution

  • 00630414589763 ()
10491448

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

RAPIDPoint® 500 Measurement Cartridge - 00630414589756

RAPIDPoint® 500 Measurement Cartridge (250 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Lac, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 500 analyzer.
Siemens Healthcare Diagnostics Inc.
10491447
In Commercial Distribution

  • 00630414589756 ()
10491447

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

ADVIA Centaur® CHIV - 00630414589749

ADVIA Centaur® CHIV assay (100 tests)
Siemens Healthcare Diagnostics Inc.
10696880
In Commercial Distribution

  • 00630414589749 ()
10696880

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

RAPIDPoint® 500 System - 00630414589169

The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, FO2Hb, FCOHb, FMetHb, FHHb, nBili
Siemens Healthcare Diagnostics Inc.
10492730
In Commercial Distribution

  • 00630414589169 ()
10492730

  • Blood gas/haemoximetry analyser IVD, point-of-care

VERSANT® Lysis Buffer Kit - 00630414589046

VERSANT® Lysis Buffer Kit
Siemens Healthcare Diagnostics Inc.
10634919
In Commercial Distribution

  • 00630414589046 ()
10634919

  • Nucleic acid extraction/isolation kit IVD

ADVIA Centaur CMV IgG - 00630414588872

CMV IgG ADVIA Centaur - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10632820
In Commercial Distribution

  • 00630414588872 ()
10632820

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

VERSANT® Tissue Preparation Reagents (Box 3) - 00630414588810

VERSANT® Tissue Preparation Reagents (Box 3)
Siemens Healthcare Diagnostics Inc.
10632400
In Commercial Distribution

  • 00630414588810 ()
10632400

  • Nucleic acid extraction/isolation kit IVD

VERSANT® Tissue Preparation Reagents, (Box 2) - 00630414588803

VERSANT® Tissue Preparation Reagents, (Box 2)
Siemens Healthcare Diagnostics Inc.
10632399
In Commercial Distribution

  • 00630414588803 ()
10632399

  • Nucleic acid extraction/isolation kit IVD

VERSANT® Tissue Preparation Reagents (Box 1) - 00630414588797

VERSANT® Tissue Preparation Reagents (Box 1)
Siemens Healthcare Diagnostics Inc.
10632398
In Commercial Distribution

  • 00630414588797 ()
10632398

  • Nucleic acid extraction/isolation kit IVD

ADVIA Centaur® VitD Diluent Bottle - 00630414588773

Vitamin D Diluent Bottle - CENTAUR - CONS - 1x25mL
Siemens Healthcare Diagnostics Inc.
10632114
In Commercial Distribution

  • 00630414588773 ()
10632114

  • Buffered sample diluent IVD

ADVIA Centaur® aTPO MCM - 00630414588476

TPO Ab Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10630890
In Commercial Distribution

  • 00630414588476 ()
10630890

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control

ADVIA Centaur® Systems QC anti-TPO 1,2 - 00630414587936

TPO Ab - CENTAUR - CONS - 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10630936
In Commercial Distribution

  • 00630414587936 ()
10630936

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control

ADVIA Centaur® Systems Calibrator 0 - 00630414587912

TPO Ab - CENTAUR - CAL - 2 x2x1mL
Siemens Healthcare Diagnostics Inc.
10630932
In Commercial Distribution

  • 00630414587912 ()
10630932

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, calibrator
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