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

  • 00630414517711 ()
3059160

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry
Pre-Albumin - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10318214
In Commercial Distribution

  • 00630414517704 ()
3057680

  • Prealbumin (transthyretin) 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
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
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
Uric Acid - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10341133
In Commercial Distribution

  • 00630414517650 ()
3051305

  • Uric acid IVD, kit, spectrophotometry
Microalbumin - ADVIA Chem. - RGT - 4x105/4x130 tests
Siemens Healthcare Diagnostics Inc.
10318197
In Commercial Distribution

  • 00630414517643 ()
3051194

  • Microalbumin IVD, kit, nephelometry/turbidimetry
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
Urea Nitrogen - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10309051
In Commercial Distribution

  • 00630414517513 ()
3040257

  • Urea IVD, kit, enzyme spectrophotometry
AST/GOT - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10341132
In Commercial Distribution

  • 00630414517506 ()
3039631

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Creatinine Jaffe - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10309050
In Commercial Distribution

  • 00630414517490 ()
3039070

  • Creatinine IVD, kit, spectrophotometry
ALT/GPT - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10318168
In Commercial Distribution

  • 00630414517483 ()
3036926

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry
Amylase - ADVIA Chem. - RGT - 7x355 tests
Siemens Healthcare Diagnostics Inc.
10341130
In Commercial Distribution

  • 00630414517452 ()
3031177

  • Total amylase IVD, kit, spectrophotometry
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
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
Siemens Healthcare Diagnostics Inc.
10318817
In Commercial Distribution

  • 00630414517360 ()
085-A001-01

  • Microscope slide maker/stainer IVD
Troponin I - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10317709
In Commercial Distribution

  • 00630414516226 ()
2790309

  • Troponin I IVD, kit, chemiluminescent immunoassay
Troponin I - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10317708
In Commercial Distribution

  • 00630414516219 ()
2789602

  • Troponin I IVD, kit, chemiluminescent immunoassay
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 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 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
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
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
Probe Wash 2 - CENTAUR - CONS - 2x25mL
Siemens Healthcare Diagnostics Inc.
10316997
In Commercial Distribution

  • 00630414514413 ()
  • 00630414003528 ()
2416113

  • Buffered wash solution IVD
Iron - ADVIA Chem. - RGT - 7x145 tests
Siemens Healthcare Diagnostics Inc.
10341118
In Commercial Distribution

  • 00630414513157 ()
2194838

  • Iron IVD, kit, spectrophotometry
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
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
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
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
PCHE - ADVIA Chem. - RGT - 4x234 tests
Siemens Healthcare Diagnostics Inc.
10315176
In Commercial Distribution

  • 00630414510149 ()
1410545

  • Acetylcholinesterase IVD, kit, spectrophotometry
Lithium - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10312850
Not in Commercial Distribution

  • 00630414509778 ()
141230

  • Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy
HIV 1/O/2 Enhanced (EHIV) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309010
Not in Commercial Distribution

  • 00630414509372 ()
1324827

  • HIV1/HIV2 antibody IVD, control
HAV total QC kit - CENTAUR - CTL - 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10309005
In Commercial Distribution

  • 00630414509259 ()
1313752

  • Hepatitis A virus total antibody IVD, control
HDL Cholesterol - ADVIA Chem. - RGT - 4x326 tests
Siemens Healthcare Diagnostics Inc.
10309507
Not in Commercial Distribution

  • 00630414508436 ()
7511947

  • High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
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