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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CO2 enzymatic - ADVIA Chem. - RGT - 1200 tests
Siemens Healthcare Diagnostics Inc.
10326480
Not in Commercial Distribution

  • 00630414505497 ()
  • 00630414003610 ()
7506781

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry
Total HCG (Ref) - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10331723
In Commercial Distribution

  • 00630414505183 ()
  • 00630414010694 ()
644127

  • Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay
HCG Total - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10308985
In Commercial Distribution

  • 00630414505176 ()
  • 00630414003016 ()
643953

  • Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay
HCG Total - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10308984
In Commercial Distribution

  • 00630414505152 ()
638631

  • Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay
HCG Total - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10308986
In Commercial Distribution

  • 00630414504797 ()
649625

  • Multiple human hormone IVD, calibrator
Total HCG B (6PK) (US) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10331729
In Commercial Distribution

  • 00630414504773 ()
652707

  • Multiple human hormone IVD, calibrator
Total HCG B (6PK) (Ref) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10331732
In Commercial Distribution

  • 00630414504759 ()
654254

  • Multiple human hormone IVD, calibrator
HCG Total Master Curve Material Set (US) - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10308987
In Commercial Distribution

  • 00630414504742 ()
655293

  • Total human chorionic gonadotropin IVD, control
ADVIA® Autoslide Modified Wright's Buffer
Siemens Healthcare Diagnostics Inc.
10327577
In Commercial Distribution

  • 00630414503967 ()
8100290

  • Phosphate buffer/Sorenson buffer solution IVD
ADVIA® Autoslide Wright-Giema Stain
Siemens Healthcare Diagnostics Inc.
10327572
In Commercial Distribution

  • 00630414503950 ()
8097532

  • Phosphate buffer/Sorenson buffer solution IVD
No Description
Siemens Healthcare Diagnostics Inc.
10327567
In Commercial Distribution

  • 00630414503943 ()
8096412

  • Reagent grade alcohol solution IVD
ADVIA® Autoslide Modified Wright's Stain
Siemens Healthcare Diagnostics Inc.
10327576
In Commercial Distribution

  • 00630414503936 ()
8100142

  • Biological stain IVD
ADVIA® Autoslide Wright-Giemsa Stain
Siemens Healthcare Diagnostics Inc.
10327568
In Commercial Distribution

  • 00630414503929 ()
8096536

  • Biological stain IVD
Reagent 1 and 2 set - CENTAUR - CONS - 1000 Best.
Siemens Healthcare Diagnostics Inc.
10313526
In Commercial Distribution

  • 00630414503875 ()
497043

  • Chemiluminescent immunoassay signal generation kit IVD
Pyridoxal-5-Phosphate Reagents
Siemens Healthcare Diagnostics Inc.
10326245
In Commercial Distribution

  • 00630414501789 ()
  • 00630414003597 ()
7371282

  • Alanine aminotransferase (ALT) IVD, reagent
Salicylate - ADVIA Chem. - RGT - 4x150 tests
Siemens Healthcare Diagnostics Inc.
10327382
In Commercial Distribution

  • 00630414498959 ()
7989456

  • Salicylate IVD, kit, enzyme spectrophotometry
Acetaminophen - ADVIA Chem. - RGT - 4x150 tests
Siemens Healthcare Diagnostics Inc.
10327381
In Commercial Distribution

  • 00630414498942 ()
7989138

  • Acetaminophen IVD, kit, enzyme immunoassay (EIA)
CO2 enzymatic - ADVIA Chem. - RGT - 4x600 tests
Siemens Healthcare Diagnostics Inc.
10327377
Not in Commercial Distribution

  • 00630414498928 ()
  • 00630414003634 ()
7987100

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry
HAV Total Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309522
In Commercial Distribution

  • 00630414498461 ()
7720961

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
HBc Total (HBcT) Assay Kit 200T
Siemens Healthcare Diagnostics Inc.
10309508
In Commercial Distribution

  • 00630414498096 ()
7566733

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
HBc Total (HBcT) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309509
In Commercial Distribution

  • 00630414498089 ()
7569996

  • Hepatitis B virus core total antibody IVD, control
The DCA™ Hemoglobin A1c Control Kit contains both NORMAL Controls and ABNORMAL Controls which are prepared as a stabilized hemolysate from human blood. The DCA Hemoglobin A1c Control Kit has been designed for use with DCA™ Analyzers.
Siemens Healthcare Diagnostics Inc.
10311161
In Commercial Distribution

  • 00630414497105 ()
5068A

  • Glycated haemoglobin (HbA1c) IVD, control
Ready Sensor™ pCO2 Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10321857
In Commercial Distribution

  • 00630414492667 ()
5065729

  • Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE)
Ready Sensor™ pO2 Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10321856
In Commercial Distribution

  • 00630414492650 ()
5065575

  • Blood oxygen electrode IVD
Reference Electrode Refill. An in vitro diagnostic device for use on the RAPIDLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10324388
In Commercial Distribution

  • 00630414492643 ()
6451843

  • Ion selective electrode (ISE) reference solution IVD, reagent
Ready Sensor™ Reference Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10324386
In Commercial Distribution

  • 00630414492636 ()
6449458

  • Ion selective electrode (ISE) reference solution IVD, reagent
RAPIDLab® 1200 Series CO-ox Sample Chamber for in vitro diagnostics use.
Siemens Healthcare Diagnostics Inc.
10324165
In Commercial Distribution

  • 00630414492629 ()
6324604

  • Blood gas/haemoximetry analyser IVD, point-of-care
RAPIDLab® 1200 Systems Wash Cartridge, for in vitro diagnostic use with RAPIDLab® 1200 series systems
Siemens Healthcare Diagnostics Inc.
10319817
In Commercial Distribution

  • 00630414492612 ()
3913056

  • Multiple blood gas analyte IVD, calibrator
RAPIDLab® 1200 Systems Reagent Cartridge for in vitro diagnostics use with the RAPIDLab 1200 series systems.
Siemens Healthcare Diagnostics Inc.
10319811
In Commercial Distribution

  • 00630414492605 ()
3909458

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
ADVIA® Autoslide Rinse
Siemens Healthcare Diagnostics Inc.
10325262
In Commercial Distribution

  • 00630414491509 ()
6837687

  • Wash/cleaning solution IVD, automated/semi-automated system
Haptoglobin - ADVIA Chem. - RGT - 540 tests
Siemens Healthcare Diagnostics Inc.
10323850
Not in Commercial Distribution

  • 00630414491356 ()
6149314

  • Haptoglobin IVD, kit, nephelometry/turbidimetry
RAPIDChem® 754, RAPIDPoint® 340/350 Daily Cleaner Kit, for in vitro diagonstic use with Rapidchem® 754, Rapidpoint® 340/350 systems
Siemens Healthcare Diagnostics Inc.
10309089
In Commercial Distribution

  • 00630414484587 ()
5610166

  • Wash/cleaning solution IVD, automated/semi-automated system
Li+ Sensor module, an in vitro diagnostics device to be used on the RAPIDChem® 754 analyzer
Siemens Healthcare Diagnostics Inc.
10318482
In Commercial Distribution

  • 00630414484563 ()
3191840

  • Ion-selective analyser IVD, semi-automated
Urine Total Protein - ADVIA Chem. - CAL - 3x5mL
Siemens Healthcare Diagnostics Inc.
10311930
Not in Commercial Distribution

  • 00630414482460 ()
  • 00630414003467 ()
B03-4847-55

  • Total protein IVD, calibrator
Liquid Specific Protein - ADVIA Chem. - CAL - 6x1mL
Siemens Healthcare Diagnostics Inc.
10311929
In Commercial Distribution

  • 00630414482453 ()
B03-4845-01

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Lipase - ADVIA Chem. - RGT - 4x160 tests
Siemens Healthcare Diagnostics Inc.
10311896
In Commercial Distribution

  • 00630414482446 ()
B01-4840-01

  • Lipase IVD, kit, spectrophotometry
RF - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10311894
In Commercial Distribution

  • 00630414482385 ()
B01-4806-01

  • Rheumatoid factor IVD, kit, nephelometry/turbidimetry
Luer Capillary (pack of 20) an in vitro diagnostics device for use on the RAPIDLab® 1200 series analyzers.
Siemens Healthcare Diagnostics Inc.
10309073
In Commercial Distribution

  • 00630414482361 ()
  • 00630414009179 ()
4142460

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Chloride - ADVIA Chem. - RGT - 1 Piece
Siemens Healthcare Diagnostics Inc.
10309439
In Commercial Distribution

  • 00630414482330 ()
073-0049-01

  • Chloride (Cl-) IVD, kit, ion-selective electrode (ISE)
Potassium - ADVIA Chem. - RGT - 1 Piece
Siemens Healthcare Diagnostics Inc.
10309440
In Commercial Distribution

  • 00630414482323 ()
073-0050-01

  • Potassium (K+) IVD, kit, ion-selective electrode (ISE)
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