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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 - 00630414472812

BNP - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10309045
In Commercial Distribution

  • 00630414472812 ()
  • 00630414003023 ()
2816634

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® BNP - 00630414472805

BNP - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309044
In Commercial Distribution

  • 00630414472805 ()
2816138

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

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
Not 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
Not 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 Centaur® FOL (25-pack) - 00630414469454

TBD
Siemens Healthcare Diagnostics Inc.
10340209
In Commercial Distribution

  • 00630414469454 ()
131096

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

RAPIDPoint® 400 Measurement Cartridge - 00630414469225

RAPIDPoint® 400 Measurement Cartridge (400 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct. For in vitro diagnostic use with RAPIDPoint ® 400 systems.
Siemens Healthcare Diagnostics Inc.
10329756
In Commercial Distribution

  • 00630414469225 ()
130517

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

ADVIA Centaur® HCY MCM - 00630414468235

Homocysteine Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10310377
In Commercial Distribution

  • 00630414468235 ()
124583

  • Homocysteine IVD, control

ADVIA Centaur® HCY DIL - 00630414468211

Homocysteine Dil.RP (2PK) - CENTAUR - CAL - 2x10mL
Siemens Healthcare Diagnostics Inc.
10318677
In Commercial Distribution

  • 00630414468211 ()
  • 00630414003535 ()
124581

  • Buffered sample diluent IVD

ADVIA Centaur® Systems, ACS:180® Systems HCY Calibrator - 00630414468198

Homocysteine - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10310376
In Commercial Distribution

  • 00630414468198 ()
124579

  • Homocysteine IVD, calibrator

ADVIA Centaur® HCY - 00630414468181

Homocystein - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10310375
In Commercial Distribution

  • 00630414468181 ()
124578

  • Homocysteine IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® HCY - 00630414468174

Homocystein - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310374
In Commercial Distribution

  • 00630414468174 ()
124577

  • Homocysteine IVD, kit, chemiluminescent immunoassay

Ready Sensor™ Lactate Biosensor - 00630414468143

Ready Sensor™ Lactate Biosensor is an in vitro diagnostic medical device for the measurement of lactate in Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10316526
In Commercial Distribution

  • 00630414468143 ()
  • 00630414009445 ()
2144067

  • Lactate electrode IVD

Gas Pressure Regulator - 00630414467818

Two stage gas Pressure Regulator for Siemens Healthcare Diagnostics Blood Gas Systems
Siemens Healthcare Diagnostics Inc.
10310422
In Commercial Distribution

  • 00630414467818 ()
127191

  • Multiple blood gas analyte IVD, calibrator

ADVIA Centaur® IRI - 00630414466200

Insulin Diluent - CENTAUR - CAL - 1x10mL
Siemens Healthcare Diagnostics Inc.
10310463
In Commercial Distribution

  • 00630414466200 ()
129885

  • Buffered sample diluent IVD
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