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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® BNP MCM - 00630414472799

BNP Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10309043
In Commercial Distribution

  • 00630414472799 ()
2815905

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

ADVIA Centaur® Systems iPTH Calibrator - 00630414472553

Intact PTH - CENTAUR - CAL - 2x2x1mL
Siemens Healthcare Diagnostics Inc.
10309042
In Commercial Distribution

  • 00630414472553 ()
2698011

  • Parathyroid hormone (PTH) IVD, calibrator

ADVIA® 120/2120/2120i TESTpoint CSF Control Kit - 00630414472539

ADVIA®120/2120/2120i TESTpoint™ CSF Control Kit
Siemens Healthcare Diagnostics Inc.
10314243
In Commercial Distribution

  • 00630414472539 ()
T03-4485-01

  • Full blood count IVD, control

VERSANT® HCV RNA 3.0 ASSAY bDNA - 00630414472393

HCV RNA 3.0 Assay (bDNA) US IVD (Box 2)
Siemens Healthcare Diagnostics Inc.
10333501
Not in Commercial Distribution

  • 00630414472393 ()
2554338

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

VERSANT® HCV RNA 3.0 ASSAY bDNA - 00630414472386

HCV RNA 3.0 Assay (bDNA) US IVD (Box 1)
Siemens Healthcare Diagnostics Inc.
10333499
Not in Commercial Distribution

  • 00630414472386 ()
2553870

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

ADVIA Centaur® aHBs - 00630414471914

Anti-HBs (aHBs) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10309021
Not in Commercial Distribution

  • 00630414471914 ()
1463789

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

ADVIA Centaur® Systems aHBs QC - 00630414471860

Anti-HBs (aHBs) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309020
Not in Commercial Distribution

  • 00630414471860 ()
1453546

  • Hepatitis B virus surface total antibody IVD, control

ADVIA Centaur® H2n - 00630414471235

HER-2/neu - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10308994
In Commercial Distribution

  • 00630414471235 ()
915031

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® H2n Calibrator - 00630414471228

HER-2/Neu - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10308993
In Commercial Distribution

  • 00630414471228 ()
913551

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, calibrator

ADVIA Centaur® H2n QC - 00630414471211

HER-2/Neu - CENTAUR - CONS - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10308992
In Commercial Distribution

  • 00630414471211 ()
913276

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control

RAPIDChem® 744 - 00630414471112

The Rapidchem® 744 analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), and Cl- (chloride) or Lithium (Li+) in serum, plasma, whole blood and urine (not applicable for Lithium) samples.
Siemens Healthcare Diagnostics Inc.
10324039
In Commercial Distribution

  • 00630414471112 ()
6254738

  • Ion-selective analyser IVD, semi-automated

ADVIA® Chemistry Direct LDL Cholesterol Reagents - 00630414470542

LDL Cholesterol - ADVIA Chem. - RGT - 4x188 tests
Siemens Healthcare Diagnostics Inc.
10311891
In Commercial Distribution

  • 00630414470542 ()
B01-4760-01

  • Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry

ADVIA Centaur® Systems HBc IgM QC - 00630414470504

HBc IgM (aHBcM) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10308979
In Commercial Distribution

  • 00630414470504 ()
504945

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

ADVIA Centaur® HBc IgM - 00630414470498

HBc IgM (aHBcM) Assay Kit - 100T
Siemens Healthcare Diagnostics Inc.
10308978
In Commercial Distribution

  • 00630414470498 ()
504619

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

ADVIA® Chemistry DIG Digoxin Reagents - 00630414470375

Digoxin - ADVIA Chem. - RGT - 4x200 tests
Siemens Healthcare Diagnostics Inc.
10327549
In Commercial Distribution

  • 00630414470375 ()
B01-4769-01

  • Digoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry TDM Calibrator - 00630414470351

TDM - ADVIA Chem. - CAL - 6x3mL
Siemens Healthcare Diagnostics Inc.
10311922
In Commercial Distribution

  • 00630414470351 ()
B03-4790-01

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

ADVIA® Chemistry HDL/LDL Cholesterol Calibrator - 00630414470313

HDL/LDL Cholesterol - ADVIA Chem. - CAL - 3x1mL
Siemens Healthcare Diagnostics Inc.
10311918
In Commercial Distribution

  • 00630414470313 ()
  • 00630414003443 ()
B03-4763-01

  • Multiple lipid analyte IVD, calibrator

ADVIA Centaur® H2n MCM - 00630414469850

HER-2/NEU Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10324496
In Commercial Distribution

  • 00630414469850 ()
131217

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control

ADVIA® Chemistry CHE Cholinesterase Reagents - 00630414465401

PCHE - ADVIA Chem. - RGT - 4x133 tests
Siemens Healthcare Diagnostics Inc.
10329639
In Commercial Distribution

  • 00630414465401 ()
B01-4605-01

  • Acetylcholinesterase IVD, kit, spectrophotometry

ADVIA® Chemistry TP Total Protein II Reagents - 00630414465227

Total Protein - ADVIA Chem. - RGT - 4x850/4x700 tests
Siemens Healthcare Diagnostics Inc.
10311878
In Commercial Distribution

  • 00630414465227 ()
B01-4601-01

  • Total protein IVD, kit, spectrophotometry
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