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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® Multi-Diluent 12 - 00630414525549

Multidil 12 CSA - CENTAUR - CONS - 1x20mL
Siemens Healthcare Diagnostics Inc.
10335692
In Commercial Distribution

  • 00630414525549 ()
4786546

  • Buffered sample diluent IVD

ADVIA Centaur® PW 4 - 00630414525464

Probe Wash 4 - CENTAUR - CONS - 1x25mL
Siemens Healthcare Diagnostics Inc.
10321290
In Commercial Distribution

  • 00630414525464 ()
4750940

  • Buffered wash solution IVD

ADVIA Centaur® COR MCM - 00630414524740

Cortisol - Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10309080
In Commercial Distribution

  • 00630414524740 ()
4639454

  • Total cortisol IVD, control

ADVIA Centaur® Calibrator E - 00630414524733

(ECOR) - CENTAUR 180 - CAL E
Siemens Healthcare Diagnostics Inc.
10335532
In Commercial Distribution

  • 00630414524733 ()
4636889

  • Multiple steroid hormone IVD, calibrator

ADVIA Centaur® Systems, ACS:180® Systems CAL Calibrator E - 00630414524726

Cortisol (6PK) - CENTAUR - CAL - 6x2x2mL
Siemens Healthcare Diagnostics Inc.
10321075
In Commercial Distribution

  • 00630414524726 ()
4634762

  • Multiple steroid hormone IVD, calibrator

ADVIA Centaur® Systems ACS:180® Systems Calibrator E - 00630414524719

Cortisol (2PK) - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10309079
In Commercial Distribution

  • 00630414524719 ()
4634452

  • Multiple steroid hormone IVD, calibrator

ADVIA Centaur® COR +E - 00630414524610

Cortisol - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10321026
In Commercial Distribution

  • 00630414524610 ()
  • 00630414011158 ()
4610138

  • Total cortisol IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® COR - 00630414524603

Cortisol - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10309078
In Commercial Distribution

  • 00630414524603 ()
4610049

  • Total cortisol IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® CsA CAL - 00630414524481

Cyclosporine - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10335454
In Commercial Distribution

  • 00630414524481 ()
4567682

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

ADVIA Centaur® CsA PRE Pretreatment - 00630414524474

CSA Pretreatment - CENTAUR - CONS - 2x26mL
Siemens Healthcare Diagnostics Inc.
10335453
In Commercial Distribution

  • 00630414524474 ()
  • 00630414003689 ()
4567127

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent

ADVIA Centaur® CsA - 00630414524450

Cyclosporine - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10335448
In Commercial Distribution

  • 00630414524450 ()
4564446

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Wash 1 - 00630414524139

Wash 1 - CENTAUR - CONS - 2x2500mL
Siemens Healthcare Diagnostics Inc.
10319550
In Commercial Distribution

  • 00630414524139 ()
  • 00630414003559 ()
3773025

  • Buffered wash solution IVD

ADVIA Centaur® CsA MCM - 00630414523798

CSA Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10334651
In Commercial Distribution

  • 00630414523798 ()
3685177

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control

ADVIA Centaur® CP Immunoassay System - 00630414523286

ADVIA® CENTAUR® CP Instrument
Siemens Healthcare Diagnostics Inc.
10309710
In Commercial Distribution

  • 00630414523286 ()
086-A002-01

  • Chemiluminescent immunoassay analyser IVD

ADVIA Centaur® PW3 - 00630414519982

Probe Wash 3 Kit - CENTAUR - CONS - 1x50mL
Siemens Healthcare Diagnostics Inc.
10334314
In Commercial Distribution

  • 00630414519982 ()
3333963

  • Buffered wash solution IVD

ADVIA® Chemistry C4 Complement C4 Reagents - 00630414517742

C4 - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10309054
In Commercial Distribution

  • 00630414517742 ()
3060770

  • Complement components C4/C4c IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry C3 Complement C3 Reagents - 00630414517735

C3 - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10309053
In Commercial Distribution

  • 00630414517735 ()
3060444

  • Complement components C3/C3c IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry AAT Alpha-1-Antitrypsin Reagents - 00630414517728

a1 Antitrypsin - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10318221
Not in Commercial Distribution

  • 00630414517728 ()
3059241

  • Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry TRF Transferrin Reagents - 00630414517711

Transferrin - ADVIA Chem. - RGT - 4x110 tests
Siemens Healthcare Diagnostics Inc.
10318218
In Commercial Distribution

  • 00630414517711 ()
3059160

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry PREALB Prealbumin Reagents - 00630414517704

Pre-Albumin - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10318214
In Commercial Distribution

  • 00630414517704 ()
3057680

  • Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry IP Inorganic Phosphorus Reagents - 00630414517698

Phosphorus inorganic - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10318211
In Commercial Distribution

  • 00630414517698 ()
3056927

  • Inorganic phosphate (PO43-) IVD, kit, spectrophotometry

ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents - 00630414517681

ASLO - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10318208
In Commercial Distribution

  • 00630414517681 ()
3055483

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry APO B Reagents - 00630414517674

Apolipoprotein B - ADVIA Chem. - RGT - 2x85 tests
Siemens Healthcare Diagnostics Inc.
10318207
In Commercial Distribution

  • 00630414517674 ()
3055068

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry UA Uric Acid Reagents - 00630414517650

Uric Acid - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10341133
In Commercial Distribution

  • 00630414517650 ()
3051305

  • Uric acid IVD, kit, spectrophotometry

ADVIA® Chemistry µALB Microalbumin Reagents - 00630414517643

Microalbumin - ADVIA Chem. - RGT - 4x105/4x130 tests
Siemens Healthcare Diagnostics Inc.
10318197
In Commercial Distribution

  • 00630414517643 ()
3051194

  • Microalbumin IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry APO A1 Reagents - 00630414517636

Apolipoprotein A1 - ADVIA Chem. - RGT - 2x75 tests
Siemens Healthcare Diagnostics Inc.
10318196
In Commercial Distribution

  • 00630414517636 ()
3050910

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry UN Urea Nitrogen Reagents - 00630414517513

Urea Nitrogen - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10309051
In Commercial Distribution

  • 00630414517513 ()
3040257

  • Urea IVD, kit, enzyme spectrophotometry

ADVIA® Chemistry Aspartate Aminotransferase (AST) Reagents - 00630414517506

AST/GOT - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10341132
In Commercial Distribution

  • 00630414517506 ()
3039631

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry

ADVIA® Chemistry CREA_2 Creatinine Reagents - 00630414517490

Creatinine Jaffe - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10309050
In Commercial Distribution

  • 00630414517490 ()
3039070

  • Creatinine IVD, kit, spectrophotometry

ADVIA® Chemistry Alanine Aminotransferase ALT Reagents - 00630414517483

ALT/GPT - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10318168
In Commercial Distribution

  • 00630414517483 ()
3036926

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry

ADVIA® Chemistry AMY Amylase Reagents - 00630414517452

Amylase - ADVIA Chem. - RGT - 7x355 tests
Siemens Healthcare Diagnostics Inc.
10341130
In Commercial Distribution

  • 00630414517452 ()
3031177

  • Total amylase IVD, kit, spectrophotometry

ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents - 00630414517445

LDH P->L - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10341129
In Commercial Distribution

  • 00630414517445 ()
3030863

  • Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry

ADVIA® Chemistry LDLP Lactate Dehydrogenase Reagents - 00630414517438

LDH L->P - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10341128
In Commercial Distribution

  • 00630414517438 ()
3029628

  • Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry

ADVIA Autoslide® Slide Maker Stainer - 00630414517360

ADVIA® Autoslide Slide Maker Stainer
Siemens Healthcare Diagnostics Inc.
10318817
In Commercial Distribution

  • 00630414517360 ()
085-A001-01

  • Microscope slide maker/stainer IVD

ADVIA Centaur® TnI-Ultra™ - 00630414516226

Troponin I - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10317709
In Commercial Distribution

  • 00630414516226 ()
2790309

  • Troponin I IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® TnI-Ultra™ - 00630414516219

Troponin I - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10317708
In Commercial Distribution

  • 00630414516219 ()
2789602

  • Troponin I IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® TnI-Ultra MCM - 00630414515892

Troponin I Ultra Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10317626
In Commercial Distribution

  • 00630414515892 ()
2738323

  • Troponin I IVD, control

RAPIDLab® 1200 Series 1265 - 00630414515571

RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human blood. The 1265 can determine pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, FO2Hb, FCOHb, FMetHb, FHHb parameters
Siemens Healthcare Diagnostics Inc.
10321852
In Commercial Distribution

  • 00630414515571 ()
5063769

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

RAPIDLab® 1200 Series 1260 - 00630414515564

RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The 1260 can determine pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate parameters
Siemens Healthcare Diagnostics Inc.
10321846
In Commercial Distribution

  • 00630414515564 ()
5062460

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

RAPIDLab® 1200 Series 1245 - 00630414515557

RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The 1245 can determine pH, pCO2, pO2, tHb, nBili, FO2Hb, FCOHb, FMetHb, FHHb parameters
Siemens Healthcare Diagnostics Inc.
10321844
In Commercial Distribution

  • 00630414515557 ()
5061537

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

RAPIDLab® 1200 Series 1240 - 00630414515540

RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The 1240 can determine pH, pCO2, pO2 parameters
Siemens Healthcare Diagnostics Inc.
10321840
In Commercial Distribution

  • 00630414515540 ()
5060298

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

TB1 pO2/pCO2 Test/Blank Sensor - 00630414515250

Test/Blank Sensor in vitro diagnostics device to replace the pO2/pCO2 sensors on the 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10316620
In Commercial Distribution

  • 00630414515250 ()
2195443

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)

RL 1200 Waste Bottle Kit - 00630414515144

Waste Bottle Kit. An in vitro diagnostics device for use on the RAPIDLab® 1200 series analyzer.
Siemens Healthcare Diagnostics Inc.
10324896
In Commercial Distribution

  • 00630414515144 ()
  • 00630414010489 ()
6641057

  • Contaminated waste container

ADVIA Centaur® Ancillary Probe Wash 2 - 00630414514413

Probe Wash 2 - CENTAUR - CONS - 2x25mL
Siemens Healthcare Diagnostics Inc.
10316997
In Commercial Distribution

  • 00630414514413 ()
  • 00630414003528 ()
2416113

  • Buffered wash solution IVD

ADVIA® Chemistry IRON_2 Reagents - 00630414513157

Iron - ADVIA Chem. - RGT - 7x145 tests
Siemens Healthcare Diagnostics Inc.
10341118
In Commercial Distribution

  • 00630414513157 ()
2194838

  • Iron IVD, kit, spectrophotometry

ADVIA® Chemistry IGA_2 Reagents - 00630414513133

IgA - ADVIA Chem. - RGT - 5x75 tests
Siemens Healthcare Diagnostics Inc.
10309033
In Commercial Distribution

  • 00630414513133 ()
2194102

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry IGM_2 Reagents - 00630414513126

IgM - ADVIA Chem. - RGT - 4x90 tests
Siemens Healthcare Diagnostics Inc.
10309032
In Commercial Distribution

  • 00630414513126 ()
2193483

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry IGG_2 Reagents - 00630414513119

IgG - ADVIA Chem. - RGT - 4x90 tests
Siemens Healthcare Diagnostics Inc.
10309031
In Commercial Distribution

  • 00630414513119 ()
2193432

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III) - 00630414513102

Calcium - ADVIA Chem. - RGT - 7x290/7x230 tests
Siemens Healthcare Diagnostics Inc.
10341116
In Commercial Distribution

  • 00630414513102 ()
  • 00630414003757 ()
2189915

  • Calcium (Ca2+) IVD, kit, spectrophotometry

ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III) - 00630414513096

Calcium - ADVIA Chem. - RGT - 8x550/8x430 tests
Siemens Healthcare Diagnostics Inc.
10316612
In Commercial Distribution

  • 00630414513096 ()
  • 00630414003511 ()
2189699

  • Calcium (Ca2+) IVD, kit, spectrophotometry
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