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

  • 00630414566245 ()
10375796

  • Blood pH electrode
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)
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
TSH3-UL Master Curve Material Set - CENTAUR - CAL
Siemens Healthcare Diagnostics Inc.
10285735
In Commercial Distribution

  • 00630414565668 ()
4782400

  • Thyroid stimulating hormone (TSH) IVD, control
TBD
Siemens Healthcare Diagnostics Inc.
10361793
In Commercial Distribution

  • 00630414565583 ()
067-A020-03

  • Haematological cell analyser IVD
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
Iron - ADVIA Chem. - RGT - 6x350 tests
Siemens Healthcare Diagnostics Inc.
10377510
In Commercial Distribution

  • 00630414561974 ()
10377510

  • Iron IVD, kit, spectrophotometry
Vancomycin - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377509
In Commercial Distribution

  • 00630414561967 ()
10377509

  • Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
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)
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)
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)
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)
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)
Glucose - ADVIA Chem. - Conc. RGT - 4x2100/4x1600 tests
Siemens Healthcare Diagnostics Inc.
10377502
In Commercial Distribution

  • 00630414561899 ()
10377502

  • Glucose IVD, kit, spectrophotometry
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
Tobramycin - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10376932
In Commercial Distribution

  • 00630414561677 ()
10376932

  • Tobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Cystatin C - ADVIA Chem. - CAL - 5x2mL
Siemens Healthcare Diagnostics Inc.
10376487
Not in Commercial Distribution

  • 00630414561578 ()
10376487

  • Cystatin C IVD, calibrator
Drug 2 - ADVIA Chem. - CAL - 2x5x5mL
Siemens Healthcare Diagnostics Inc.
10376771
In Commercial Distribution

  • 00630414561332 ()
10376771

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator
Drug 1 - ADVIA Chem. - CAL - 2x5x5mL
Siemens Healthcare Diagnostics Inc.
10376770
In Commercial Distribution

  • 00630414561325 ()
10376770

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator
Cholesterol - ADVIA Chem. - RGT - 7x350/7x280 tests
Siemens Healthcare Diagnostics Inc.
10376501
In Commercial Distribution

  • 00630414561073 ()
  • 00630414003764 ()
10376501

  • Total cholesterol lipid IVD, kit, spectrophotometry
Carbamazepine - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10376342
In Commercial Distribution

  • 00630414560793 ()
10376342

  • Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
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
Siemens Healthcare Diagnostics Inc.
10285573
In Commercial Distribution

  • 00630414560045 ()
067-A013-01

  • Haematological cell analyser IVD
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
Siemens Healthcare Diagnostics Inc.
10285021
In Commercial Distribution

  • 00630414558400 ()
4871500

  • Wash/cleaning solution IVD, automated/semi-automated system
LP(A) - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285017
In Commercial Distribution

  • 00630414558257 ()
4865268

  • Lipoprotein A IVD, calibrator
Fructosamine - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285684
Not in Commercial Distribution

  • 00630414558240 ()
  • 00630414002996 ()
4865217

  • Fructosamine IVD, calibrator
Myoglobin Kit - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285682
Not in Commercial Distribution

  • 00630414558233 ()
4865160

  • Myoglobin IVD, calibrator
B2 Microglobulin - ADVIA Chem. - CAL - 3x1mL
Siemens Healthcare Diagnostics Inc.
10285680
Not in Commercial Distribution

  • 00630414558226 ()
  • 00630414002989 ()
4865101

  • Beta-2-microglobulin IVD, calibrator
Lipoprotein - ADVIA Chem. - RGT - 200 tests
Siemens Healthcare Diagnostics Inc.
10361942
In Commercial Distribution

  • 00630414558080 ()
4862528

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
Fructosamine - ADVIA Chem. - RGT - 200 tests
Siemens Healthcare Diagnostics Inc.
10361941
Not in Commercial Distribution

  • 00630414558073 ()
4862501

  • Fructosamine IVD, kit, spectrophotometry
Cystatin C - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10361930
Not in Commercial Distribution

  • 00630414557915 ()
4851534

  • Cystatin C IVD, kit, nephelometry/turbidimetry
SHBG - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10285318
Not in Commercial Distribution

  • 00630414556093 ()
4819274

  • Sex hormone binding globulin (SHBG) IVD, calibrator
Calcium - ADVIA Chem. - RGT - 6x675 tests
Siemens Healthcare Diagnostics Inc.
10286036
In Commercial Distribution

  • 00630414555904 ()
4802312

  • Calcium (Ca2+) IVD, kit, spectrophotometry
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)
Siemens Healthcare Diagnostics Inc.
10286027
In Commercial Distribution

  • 00630414555553 ()
4801685

  • Nucleic acid extraction/isolation kit IVD
VERSANT® Sample Preparation 1.0 Reagents (Box 1)
Siemens Healthcare Diagnostics Inc.
10286026
In Commercial Distribution

  • 00630414555546 ()
4801677

  • Nucleic acid extraction/isolation kit IVD
Thyroid (6PK) (Ref) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10285905
In Commercial Distribution

  • 00630414555331 ()
4800840

  • Multiple human hormone IVD, calibrator
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