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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 Chemistry Enzymatic Hemoglobin A1c - 00630414002866

ADVIA A1c_E Reagent (Large Kit), 1200 tests
Siemens Healthcare Diagnostics Inc.
10720858
In Commercial Distribution

  • 00630414002866 ()
10720858

  • Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry

ADVIA Chemistry Enzymatic Hemoglobin A1c - 00630414002859

ADVIA A1c_E Reagent (Small Kit), 300 tests
Siemens Healthcare Diagnostics Inc.
10720857
In Commercial Distribution

  • 00630414002859 ()
10720857

  • Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry

Atellica CH MULTIDRUG QC - 00630414002699

Multi-drug QC (Urine) Atellica CH - CTL 3 x 5mL
Siemens Healthcare Diagnostics Inc.
11099406
Not in Commercial Distribution

  • 00630414002699 ()
  • 00630414211572 ()
11099406

  • Multiple therapeutic drugs/drugs of abuse IVD, control

Atellica Sample Handler Additional - 00630414002460

Atellica SAMPLE HANDLER ADDITIONAL MODULE
Siemens Healthcare Diagnostics Inc.
11069004
In Commercial Distribution

  • 00630414002460 ()
11069004

  • Specimen processing instrument IVD

Atellica Sample Handler Prime - 00630414002439

Atellica SAMPLE HANDLER PRIMARY MODULE
Siemens Healthcare Diagnostics Inc.
11069001
In Commercial Distribution

  • 00630414002439 ()
11069001

  • Specimen processing instrument IVD

Atellica Direct Load Kit - 00630414002354

Atellica DL PRIMARY KIT
Siemens Healthcare Diagnostics Inc.
11068009
In Commercial Distribution

  • 00630414002354 ()
11068009

  • Specimen processing instrument IVD

Atellica Direct Load - 00630414002347

Atellica DL MODULE
Siemens Healthcare Diagnostics Inc.
11068008
In Commercial Distribution

  • 00630414002347 ()
11068008

  • Specimen processing instrument IVD

Atellica CH 930 Analyzer - 00630414002163

Atellica CH 930 Analyzer
Siemens Healthcare Diagnostics Inc.
11067000
In Commercial Distribution

  • 00630414002163 ()
11067000

  • Multiple clinical chemistry analyser IVD, laboratory

Atellica IM 1600 Analyzer - 00630414002026

Atellica IM 1600 Analyzer
Siemens Healthcare Diagnostics Inc.
11066000
In Commercial Distribution

  • 00630414002026 ()
11066000

  • Chemiluminescent immunoassay analyser IVD

Xprecia Stride™ Accessory Kit - 00630414001975

Stride Device Manager Application software kit
Siemens Healthcare Diagnostics Inc.
10714617
In Commercial Distribution

  • 00630414001975 ()
10714617

  • Medical equipment clinical data interfacing software

ADVIA Chemistry CO2_c - 00630414000541

ADVIA Chemistry CO2_c 20mL
Siemens Healthcare Diagnostics Inc.
10720780
In Commercial Distribution

  • 00630414000541 ()
  • 00630414300122 ()
10720780

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry

VERSANT - 00630414000534

LiPAScan software
Siemens Healthcare Diagnostics Inc.
10492006
In Commercial Distribution

  • 00630414000534 ()
10492006

  • Laboratory instrument/analyser application software IVD

VERSANT HCV Control 2.0 Kit (LiPA) - 00630414000510

VERSANT HCV Control 2.0 Kit
Siemens Healthcare Diagnostics Inc.
10719668
In Commercial Distribution

  • 00630414000510 ()
10719668

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

VERSANT HCV 2.0 LiPA - 00630414000503

VERSANT HCV Amplification 2.0 Kit (LiPA) 100 Test for HCV genotyping
Siemens Healthcare Diagnostics Inc.
10719667
In Commercial Distribution

  • 00630414000503 ()
10719667

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

VERSANT HCV 2.0 LiPA - 00630414000497

VERSANT HCV Amplification 2.0 Kit (LiPA) 40 Test for HCV genotyping
Siemens Healthcare Diagnostics Inc.
10719666
In Commercial Distribution

  • 00630414000497 ()
10719666

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

RAPIDComm® Data Management System - 00630414000466

The RAPIDComm® program manages the process of sending and receiving data from devices and hospital systems located anywhere in your network.
Siemens Healthcare Diagnostics Inc.
11065134
In Commercial Distribution

  • 00630414000466 ()
11065134

  • Medical equipment clinical data interfacing software

ADVIA Autoslide® Slide Maker Stainer - 00630414000220

ADVIA® Autoslide Slide Maker Stainer
Siemens Healthcare Diagnostics Inc.
10282178
In Commercial Distribution

  • 00630414000220 ()
085-A002-03

  • Microscope slide maker/stainer IVD

ADVIA® Chemistry MYO Myoglobin Reagents - 00630414000190

Myoglobin - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10361939
Not in Commercial Distribution

  • 00630414000190 ()
4862455

  • Myoglobin IVD, kit, nephelometry/turbidimetry

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
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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