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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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RAPIDPOINT® 350 Sampler Module - 00630414566313

RAPIDPOINT® 350 Sampler Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 350 analyzer
Siemens Healthcare Diagnostics Inc.
10375810
In Commercial Distribution

  • 00630414566313 ()
10375810

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

RAPIDPOINT® 340 Reagent Module - 00630414566306

RAPIDPOINT® 340 Reagent Module, pH / pCO2 / pO2, for use with Rapidpoint 340 analyzers
Siemens Healthcare Diagnostics Inc.
10375807
In Commercial Distribution

  • 00630414566306 ()
10375807

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

RAPIDPOINT® 350 Reagent Module - 00630414566290

RAPIDPOINT® 350 Reagent Module pH / pCO2 / pO2 / Na+ / K+ / Cl- / Ca++ for use with Rapidpoint 350 analyzers
Siemens Healthcare Diagnostics Inc.
10375806
In Commercial Distribution

  • 00630414566290 ()
10375806

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

RAPIDPoint ® 340/350 Capillary Tubes 100ul - 00630414566283

Capillary Tube Kit, for use with RapidPoint® 340/350 analyzers; contents: 2 vials (100 each) capillary tubes, 1 bag (500) end caps
Siemens Healthcare Diagnostics Inc.
10375804
In Commercial Distribution

  • 00630414566283 ()
10375804

  • Capillary blood collection tube IVD, lithium heparin

RAPIDPOINT® 350 Cl- Electrode - 00630414566276

RAPIDPOINT® 350 Chloride Electrode for use with Rapidpoint® 350 Analyzers.
Siemens Healthcare Diagnostics Inc.
10375802
In Commercial Distribution

  • 00630414566276 ()
10375802

  • Chloride (Cl-) IVD, kit, ion-selective electrode (ISE)

RAPIDPOINT® 340/350 pO2 Electrode - 00630414566269

RAPIDPOINT® 340/350 pO2 Electrode for use with Rapidpoint® 340/350 Analyzers.
Siemens Healthcare Diagnostics Inc.
10375798
In Commercial Distribution

  • 00630414566269 ()
10375798

  • Blood oxygen electrode IVD

RAPIDPOINT®340/350 pCO2 Electrode - 00630414566252

RAPIDPOINT® 340/350 PCO2 Electrode for use with Rapidpoint® 340/350 Analyzers.
Siemens Healthcare Diagnostics Inc.
10375797
In Commercial Distribution

  • 00630414566252 ()
10375797

  • Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE)

RAPIDPOINT®340/350 pH Electrode - 00630414566245

RAPIDPOINT® 340/350 pH Electrode for use with Rapidpoint® 340/350 Analyzers.
Siemens Healthcare Diagnostics Inc.
10375796
In Commercial Distribution

  • 00630414566245 ()
10375796

  • Blood pH electrode

RAPIDPOINT® 340 Sensor Module - 00630414566238

RAPIDPOINT® 340 Sensor Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 340 analyzer
Siemens Healthcare Diagnostics Inc.
10375809
In Commercial Distribution

  • 00630414566238 ()
10375809

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

RAPIDPoint® 350 Trouble shooting kit - 00630414566221

Trouble shooting kit for use with RAPIDPoint® 350 blood gas analyzers
Siemens Healthcare Diagnostics Inc.
10375803
In Commercial Distribution

  • 00630414566221 ()
10375803

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

ADVIA Centaur® TSH3-UL MCM - 00630414565668

TSH3-UL Master Curve Material Set - CENTAUR - CAL
Siemens Healthcare Diagnostics Inc.
10285735
In Commercial Distribution

  • 00630414565668 ()
4782400

  • Thyroid stimulating hormone (TSH) IVD, control

ADVIA(R) 2120i Hematology System - 00630414565583

TBD
Siemens Healthcare Diagnostics Inc.
10361793
In Commercial Distribution

  • 00630414565583 ()
067-A020-03

  • Haematological cell analyser IVD

ADVIA Centaur® TSH3-UL - 00630414563268

ADVIA Centaur® TSH3-UL (25-pack)
Siemens Healthcare Diagnostics Inc.
10361944
In Commercial Distribution

  • 00630414563268 ()
  • 00630414010564 ()
4862625

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

ADVIA® Chemistry IRON_2 Iron 2 Reagents - 00630414561974

Iron - ADVIA Chem. - RGT - 6x350 tests
Siemens Healthcare Diagnostics Inc.
10377510
In Commercial Distribution

  • 00630414561974 ()
10377510

  • Iron IVD, kit, spectrophotometry

ADVIA® Chemistry VANC_2 Vancomycin_2 Reagents - 00630414561967

Vancomycin - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377509
Not in Commercial Distribution

  • 00630414561967 ()
10377509

  • Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry VPA_2 Valproic Acid_2 Reagents - 00630414561950

Valproic Acid - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377508
In Commercial Distribution

  • 00630414561950 ()
10377508

  • Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry GENT_2 Gentamicin_2 Reagents - 00630414561943

Gentamicin - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377507
In Commercial Distribution

  • 00630414561943 ()
10377507

  • Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry PHNY_2 Phenytoin_2 Reagents - 00630414561936

Phenytoin - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377506
In Commercial Distribution

  • 00630414561936 ()
10377506

  • Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry PHNB_2 Phenobarbital_2 Reagents - 00630414561929

Phenobarbital - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377505
In Commercial Distribution

  • 00630414561929 ()
10377505

  • Phenobarbital therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry THEO_2 Theophylline_2 Reagents - 00630414561905

Theophyline - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377503
In Commercial Distribution

  • 00630414561905 ()
10377503

  • Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry GLUH_c Glucose Hexokinase_3 Reagents, Concentrated - 00630414561899

Glucose - ADVIA Chem. - Conc. RGT - 4x2100/4x1600 tests
Siemens Healthcare Diagnostics Inc.
10377502
In Commercial Distribution

  • 00630414561899 ()
10377502

  • Glucose IVD, kit, spectrophotometry

ADVIA Centaur® aHBs2 - 00630414561790

Anti-HBs2 (aHBs2) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10286268
In Commercial Distribution

  • 00630414561790 ()
4670661

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

ADVIA® Chemistry TOB_2 Tobramycin_2 Reagents - 00630414561677

Tobramycin - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10376932
Not in Commercial Distribution

  • 00630414561677 ()
10376932

  • Tobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry CYSC Cystatin-C Calibrators - 00630414561578

Cystatin C - ADVIA Chem. - CAL - 5x2mL
Siemens Healthcare Diagnostics Inc.
10376487
Not in Commercial Distribution

  • 00630414561578 ()
10376487

  • Cystatin C IVD, calibrator

ADVIA® Chemistry Drug Calibrator II - 00630414561332

Drug 2 - ADVIA Chem. - CAL - 2x5x5mL
Siemens Healthcare Diagnostics Inc.
10376771
Not in Commercial Distribution

  • 00630414561332 ()
10376771

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

ADVIA® Chemistry Drug Calibrator I - 00630414561325

Drug 1 - ADVIA Chem. - CAL - 2x5x5mL
Siemens Healthcare Diagnostics Inc.
10376770
In Commercial Distribution

  • 00630414561325 ()
10376770

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

ADVIA Centaur® HBcT2 Quality Control Kit - 00630414561233

ADVIA Centaur® HBcT2
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10376699
In Commercial Distribution

  • 00630414210766 ()
  • 00630414561233 ()
10376699

  • Hepatitis B virus core total antibody IVD, control

ADVIA Centaur® HBcT2 - 00630414561226

ADVIA Centaur® HBcT2
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10376698
In Commercial Distribution

  • 00630414561226 ()
10376698

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

ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent - 00630414561073

Cholesterol - ADVIA Chem. - RGT - 7x350/7x280 tests
Siemens Healthcare Diagnostics Inc.
10376501
In Commercial Distribution

  • 00630414561073 ()
  • 00630414003764 ()
10376501

  • Total cholesterol lipid IVD, kit, spectrophotometry

ADVIA® Chemistry CARB_2 Reagents - 00630414560793

Carbamazepine - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10376342
Not in Commercial Distribution

  • 00630414560793 ()
10376342

  • Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA Autoslide® Slide Maker Stainer - 00630414560595

ADVIA® Autoslide Slide Maker Stainer
Siemens Healthcare Diagnostics Inc.
10282177
In Commercial Distribution

  • 00630414560595 ()
085-A001-02

  • Microscope slide maker/stainer IVD

ADVIA® 2120i Hematology System - 00630414560045

ADVIA®2120i Hematology System
Siemens Healthcare Diagnostics Inc.
10285573
In Commercial Distribution

  • 00630414560045 ()
067-A013-01

  • Haematological cell analyser IVD

ADVIA Centaur® T3 MCM - 00630414559704

T3 Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10361928
In Commercial Distribution

  • 00630414559704 ()
4848169

  • Total triiodothyronine (TT3) IVD, control

ADVIA ® 120/2120/2120i EZ WASH - 00630414558400

ADVIA®120/2120/2120i EZ WASH
Siemens Healthcare Diagnostics Inc.
10285021
In Commercial Distribution

  • 00630414558400 ()
4871500

  • Wash/cleaning solution IVD, automated/semi-automated system

ADVIA® Chemistry LP(A) CALIBRATOR - 00630414558257

LP(A) - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285017
In Commercial Distribution

  • 00630414558257 ()
4865268

  • Lipoprotein A IVD, calibrator

ADVIA® Chemistry FRUC Calibrator - 00630414558240

Fructosamine - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285684
Not in Commercial Distribution

  • 00630414558240 ()
  • 00630414002996 ()
4865217

  • Fructosamine IVD, calibrator

ADVIA® Chemistry MYO CALIBRATOR - 00630414558233

Myoglobin Kit - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285682
Not in Commercial Distribution

  • 00630414558233 ()
4865160

  • Myoglobin IVD, calibrator

ADVIA® Chemistry B2M CAL Beta-2-Microglobulin Calibrator - 00630414558226

B2 Microglobulin - ADVIA Chem. - CAL - 3x1mL
Siemens Healthcare Diagnostics Inc.
10285680
Not in Commercial Distribution

  • 00630414558226 ()
  • 00630414002989 ()
4865101

  • Beta-2-microglobulin IVD, calibrator

ADVIA® Chemistry LP(A) Lipoprotein(a) Reagents - 00630414558080

Lipoprotein - ADVIA Chem. - RGT - 200 tests
Siemens Healthcare Diagnostics Inc.
10361942
In Commercial Distribution

  • 00630414558080 ()
4862528

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry FRUC Reagents - 00630414558073

Fructosamine - ADVIA Chem. - RGT - 200 tests
Siemens Healthcare Diagnostics Inc.
10361941
Not in Commercial Distribution

  • 00630414558073 ()
4862501

  • Fructosamine IVD, kit, spectrophotometry

ADVIA® Chemistry CYSC Cystatin-C Reagents - 00630414557915

Cystatin C - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10361930
Not in Commercial Distribution

  • 00630414557915 ()
4851534

  • Cystatin C IVD, kit, nephelometry/turbidimetry

ADVIA Centaur® SHBG Calibrator - 00630414556093

SHBG - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10285318
Not in Commercial Distribution

  • 00630414556093 ()
4819274

  • Sex hormone binding globulin (SHBG) IVD, calibrator

ADVIA® Chemistry CPC Calcium Reagents - 00630414555904

Calcium - ADVIA Chem. - RGT - 6x675 tests
Siemens Healthcare Diagnostics Inc.
10286036
In Commercial Distribution

  • 00630414555904 ()
4802312

  • Calcium (Ca2+) IVD, kit, spectrophotometry

ADVIA® Chemistry AMM Ammonia Reagents - 00630414555898

Ammonia - ADVIA Chem. - RGT - 2x138 tests
Siemens Healthcare Diagnostics Inc.
10286035
In Commercial Distribution

  • 00630414555898 ()
4802290

  • Ammonia IVD, kit, spectrophotometry

VERSANT® Sample Preparation 1.0 Reagents (Box 2) - 00630414555553

VERSANT® Sample Preparation 1.0 Reagents (Box 2)
Siemens Healthcare Diagnostics Inc.
10286027
Not in Commercial Distribution

  • 00630414555553 ()
4801685

  • Nucleic acid extraction/isolation kit IVD

VERSANT® Sample Preparation 1.0 Reagents (Box 1) - 00630414555546

VERSANT® Sample Preparation 1.0 Reagents (Box 1)
Siemens Healthcare Diagnostics Inc.
10286026
Not in Commercial Distribution

  • 00630414555546 ()
4801677

  • Nucleic acid extraction/isolation kit IVD

ADVIA Centaur® Calibrator A - 00630414555331

Thyroid (6PK) (Ref) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10285905
In Commercial Distribution

  • 00630414555331 ()
4800840

  • Multiple human hormone IVD, calibrator

ADVIA Centaur® ACS:180® Calibrator A - 00630414555324

Thyroid (6PK) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10285904
In Commercial Distribution

  • 00630414555324 ()
4800735

  • Multiple human hormone IVD, calibrator

ADVIA Centaur® ACS:180® Calibrator A - 00630414555317

Thyroid (2PK) - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10285903
In Commercial Distribution

  • 00630414555317 ()
4800646

  • Multiple human hormone IVD, calibrator

ADVIA Centaur® Systems aHBs2 MCM - 00630414555300

aHBs2 Master Curve Material
Siemens Healthcare Diagnostics Inc.
10285962
In Commercial Distribution

  • 00630414555300 ()
4800387

  • Hepatitis B virus surface total antibody IVD, control
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