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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DHEA-S Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10282214
In Commercial Distribution

  • 00630414535340 ()
6489752

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control
DHEA-S - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10282227
In Commercial Distribution

  • 00630414535333 ()
6489701

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
ADVIA® 1800 Instrument
Siemens Healthcare Diagnostics Inc.
10315183
In Commercial Distribution

  • 00630414534794 ()
073-A021-01

  • Multiple clinical chemistry analyser IVD, laboratory
CRP 2 - ADVIA Chem. - CAL - 6x1mL
Siemens Healthcare Diagnostics Inc.
10337471
In Commercial Distribution

  • 00630414534244 ()
6487741

  • C-reactive protein (CRP) IVD, calibrator
Microalbumin - ADVIA Chem. - CAL - 5x2mL
Siemens Healthcare Diagnostics Inc.
10337470
In Commercial Distribution

  • 00630414534077 ()
6487733

  • Microalbumin IVD, calibrator
Quality control for Siemens urine strips read visually and all analyzers other than Clinitek Atlas® and Clinitek Novus® - 25 positive strips
Siemens Healthcare Diagnostics Inc.
10310482
In Commercial Distribution

  • 00630414532844 ()
  • 00630414009230 ()
1360

  • Multiple urine analyte IVD, control
Quality control for Siemens urine strips read visually and all analyzers other than Clinitek Atlas® and Clinitek Novus® - 25 positive and 25 negative strips
Siemens Healthcare Diagnostics Inc.
10310483
In Commercial Distribution

  • 00630414532837 ()
1364

  • Multiple urine analyte IVD, control
DCA HbA1c Test Kit (monitoring only) - INTL.
Siemens Healthcare Diagnostics Inc.
10311134
In Commercial Distribution

  • 00630414532806 ()
5035C

  • Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography
DCA Microablumin Creatinine Test Kit (ACR test).
Siemens Healthcare Diagnostics Inc.
10311480
In Commercial Distribution

  • 00630414532790 ()
6011A

  • Microalbumin IVD, kit, spectrophotometry
Valproic Acid Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10322232
Not in Commercial Distribution

  • 00630414527369 ()
5261307

  • Valproic acid therapeutic drug monitoring IVD, control
Valproic Acid - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10322222
Not in Commercial Distribution

  • 00630414527345 ()
5259132

  • Valproic acid therapeutic drug monitoring IVD, calibrator
Gentamicin Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10322163
Not in Commercial Distribution

  • 00630414527307 ()
5227559

  • Gentamicin therapeutic drug monitoring IVD, control
Gentamicin - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10322159
Not in Commercial Distribution

  • 00630414527284 ()
5226110

  • Gentamicin therapeutic drug monitoring IVD, calibrator
Phenobarbital - CENTAUR - CAL - 6x2x2mL
Siemens Healthcare Diagnostics Inc.
10322093
Not in Commercial Distribution

  • 00630414527215 ()
5191007

  • Phenobarbital therapeutic drug monitoring IVD, calibrator
Phenobarbital - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10322090
Not in Commercial Distribution

  • 00630414527192 ()
5190841

  • Phenobarbital therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
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
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
Transferrin - ADVIA Chem. - RGT - 4x110 tests
Siemens Healthcare Diagnostics Inc.
10318218
In Commercial Distribution

  • 00630414517711 ()
3059160

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry
Phosphorus inorganic - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10318211
In Commercial Distribution

  • 00630414517698 ()
3056927

  • Inorganic phosphate (PO43-) IVD, kit, spectrophotometry
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 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 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
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)
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
Iron - ADVIA Chem. - RGT - 7x145 tests
Siemens Healthcare Diagnostics Inc.
10341118
In Commercial Distribution

  • 00630414513157 ()
2194838

  • Iron IVD, kit, spectrophotometry
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
Calcium - ADVIA Chem. - RGT - 7x290/7x230 tests
Siemens Healthcare Diagnostics Inc.
10341116
In Commercial Distribution

  • 00630414513102 ()
  • 00630414003757 ()
2189915

  • Calcium (Ca2+) IVD, kit, spectrophotometry
Calcium - ADVIA Chem. - RGT - 8x550/8x430 tests
Siemens Healthcare Diagnostics Inc.
10316612
In Commercial Distribution

  • 00630414513096 ()
  • 00630414003511 ()
2189699

  • Calcium (Ca2+) IVD, kit, spectrophotometry
Bilirubin Direct - ADVIA Chem. - RGT - 4x130 tests
Siemens Healthcare Diagnostics Inc.
10316610
In Commercial Distribution

  • 00630414513089 ()
2189494

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry
Bilirubin Total - ADVIA Chem. - RGT - 4x356 tests
Siemens Healthcare Diagnostics Inc.
10341115
Not in Commercial Distribution

  • 00630414513072 ()
2189346

  • Total bilirubin IVD, kit, spectrophotometry
Bilirubin Direct - ADVIA Chem. - RGT - 4x672 tests
Siemens Healthcare Diagnostics Inc.
10341114
In Commercial Distribution

  • 00630414513065 ()
2188390

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry
Bilirubin Total - ADVIA Chem. - RGT - 4x672 tests
Siemens Healthcare Diagnostics Inc.
10341113
In Commercial Distribution

  • 00630414513058 ()
2188064

  • Total bilirubin IVD, kit, spectrophotometry
RAPIDLyte Multicap-S plastic blood collection capillary tubes (500 tubes) approx. volume 175µL. For capillary blood collection for the analysis of pH/Blood Gas/Na+/Li+/Ca++/Cl-/Glu/Lac/tHb
Siemens Healthcare Diagnostics Inc.
10316361
In Commercial Distribution

  • 00630414511542 ()
  • 00630414009438 ()
2043295

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
RAPIDLyte Multicap-S plastic blood collection capillary tubes (50 tubes) approx. volume 175µL. For capillary blood collection for the analysis of pH/Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb
Siemens Healthcare Diagnostics Inc.
10324363
In Commercial Distribution

  • 00630414511535 ()
  • 00630414009551 ()
6440221

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
RAPIDLyte Multicap-S plastic blood collection capillary tubes (500 tubes) approx. volume 100µL. For capillary blood collection for the analysis of pH/Blood Gas/Na+/K/Ca++/Cl-/Glu/Lac/tHb.
Siemens Healthcare Diagnostics Inc.
10322986
In Commercial Distribution

  • 00630414511528 ()
  • 00630414009513 ()
5656514

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
RAPIDLyte Multicap-S plastic blood collection capillary tubes (50 tubes) approx. volume 100µL. For capillary blood collection for the analysis of pH/Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb.
Siemens Healthcare Diagnostics Inc.
10313252
In Commercial Distribution

  • 00630414511511 ()
  • 00630414009391 ()
335434

  • Capillary blood collection tube IVD, no additive
HIV 1/O/2 Enhanced (EHIV) (1-pack) 200T Assay Kit
Siemens Healthcare Diagnostics Inc.
10332613
In Commercial Distribution

  • 00630414511245 ()
1622429

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
Ready Sensor™ Calcium Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10315219
In Commercial Distribution

  • 00630414510293 ()
  • 00630414010137 ()
1428622

  • Calcium (Ca2+) electrode IVD
Pyridoxal-5-Phosphate Reagents
Siemens Healthcare Diagnostics Inc.
10315181
In Commercial Distribution

  • 00630414510163 ()
  • 00630414003498 ()
1411533

  • Alanine aminotransferase (ALT) IVD, reagent
Amylase pancreatic - ADVIA Chem. - RGT - 7x130 tests
Siemens Healthcare Diagnostics Inc.
10315178
In Commercial Distribution

  • 00630414510156 ()
1410820

  • Amylase isoenzyme IVD, kit, spectrophotometry
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