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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TSH - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309958
In Commercial Distribution

  • 00630414177021 ()
110732

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
T3/T4/Vit-B12 ANC Reagent - CENTAUR - CAL - 6x25mL
Siemens Healthcare Diagnostics Inc.
10309954
In Commercial Distribution

  • 00630414175386 ()
  • 00630414003184 ()
110329

  • Multiple thyroid marker IVD, reagent
T3/T4/Vit.B12 ANC Reagent - CENTAUR - CAL - 2x25mL
Siemens Healthcare Diagnostics Inc.
10319315
In Commercial Distribution

  • 00630414175379 ()
  • 00630414003542 ()
110328

  • Multiple thyroid marker IVD, reagent
IgE Dil.RP (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309952
In Commercial Distribution

  • 00630414175331 ()
  • 00630414003177 ()
110324

  • Buffered sample diluent IVD
CKMB Dil.RP (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309951
In Commercial Distribution

  • 00630414175324 ()
  • 00630414003160 ()
110323

  • Buffered sample diluent IVD
CEA Dil.RP (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309950
In Commercial Distribution

  • 00630414175317 ()
  • 00630414003153 ()
110322

  • Buffered sample diluent IVD
VitaminB 12 Dil.RP (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309949
In Commercial Distribution

  • 00630414175300 ()
  • 00630414003146 ()
110321

  • Buffered sample diluent IVD
Multidil 7 (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309947
Not in Commercial Distribution

  • 00630414175270 ()
  • 00630414003139 ()
110318

  • Buffered sample diluent IVD
Multidil 5Readypack (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309946
Not in Commercial Distribution

  • 00630414175263 ()
  • 00630414003122 ()
110317

  • Buffered sample diluent IVD
Multidil 4 (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309945
In Commercial Distribution

  • 00630414175256 ()
  • 00630414003115 ()
110316

  • Buffered sample diluent IVD
Multidil3Readypack (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309944
In Commercial Distribution

  • 00630414175249 ()
  • 00630414003108 ()
110315

  • Buffered sample diluent IVD
Blank sensor to replace the K+/Ca++/Cl-sensor. An in vitro medical device used on Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10311665
In Commercial Distribution

  • 00630414132075 ()
673702

  • Blood gas/haemoximetry analyser IVD, point-of-care
Blank Sensor used For GLU or LAC on Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10326708
In Commercial Distribution

  • 00630414132051 ()
673701000

  • Lactate electrode IVD
Reference Test/Blank sensor, an in vitro diagnostics device to replace the Reference sensor on the RAPIDLab® 248/348/348ex analyzers
Siemens Healthcare Diagnostics Inc.
10327492
In Commercial Distribution

  • 00630414132013 ()
673396000

  • Blood gas/haemoximetry analyser IVD, point-of-care
RAPIDLyte Multicap 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.
10323539
In Commercial Distribution

  • 00630414131986 ()
  • 00630414009520 ()
673394

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
Prolactin Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311626
In Commercial Distribution

  • 00630414126326 ()
672430000

  • Prolactin IVD, control
Alpha-Fetoprotein (AFP) Master Curve Material Kit
Siemens Healthcare Diagnostics Inc.
10311625
In Commercial Distribution

  • 00630414126319 ()
672428000

  • Alpha-fetoprotein (AFP) IVD, control
CEA Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311624
In Commercial Distribution

  • 00630414126302 ()
672427000

  • Carcinoembryonic antigen (CEA) IVD, control
Digoxin Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311623
In Commercial Distribution

  • 00630414126296 ()
672426000

  • Digoxin therapeutic drug monitoring IVD, control
Free T3 Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311622
In Commercial Distribution

  • 00630414126289 ()
672425000

  • Free triiodothyronine (FT3) IVD, control
IgE Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311621
In Commercial Distribution

  • 00630414126265 ()
672423000

  • Total immunoglobulin E (IgE total) IVD, control
TSH Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311620
In Commercial Distribution

  • 00630414126258 ()
672422000

  • Thyroid stimulating hormone (TSH) IVD, control
T4 Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311619
In Commercial Distribution

  • 00630414126234 ()
672420000

  • Total thyroxine (TT4) IVD, control
Follicular Stimulating Hormone Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311617
In Commercial Distribution

  • 00630414126210 ()
672418000

  • Follicle stimulating hormone (FSH) IVD, control
Ferritin Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311616
In Commercial Distribution

  • 00630414126197 ()
672416000

  • Ferritin IVD, control
Vancomycin Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311613
Not in Commercial Distribution

  • 00630414126111 ()
672362000

  • Vancomycin therapeutic drug monitoring IVD, control
T3 Diluent - CENTAUR - CAL - 1x10mL
Siemens Healthcare Diagnostics Inc.
10311588
In Commercial Distribution

  • 00630414125176 ()
672207000

  • Buffered sample diluent IVD
T4 Diluent - CENTAUR - CAL - 1x10mL
Siemens Healthcare Diagnostics Inc.
10311585
In Commercial Distribution

  • 00630414125121 ()
672202000

  • Buffered sample diluent IVD
Calibrator D - 6 pack (AFP Cal; CEA Cal)
Siemens Healthcare Diagnostics Inc.
10331182
In Commercial Distribution

  • 00630414124940 ()
672183005

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
Calibrator D - 6 pack (AFP Cal; CEA Cal)
Siemens Healthcare Diagnostics Inc.
10311576
In Commercial Distribution

  • 00630414124933 ()
672183000

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
Ferritin/VitB12 (Ref) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10334728
In Commercial Distribution

  • 00630414124926 ()
672182005

  • Multiple anaemia-related analyte IVD, calibrator
High Sensitivity Troponin I (TnIH) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206269
In Commercial Distribution

  • 00630414293783 ()
11206269

  • Troponin I IVD, kit, chemiluminescent immunoassay
T3 Total (T3) - Atellica IM - RGT 600T
Siemens Healthcare Diagnostics Inc.
11206260
In Commercial Distribution

  • 00630414294247 ()
  • 00630414293769 ()
11206260

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
Intact Parathyroid Hormone (PTH) - Atellica IM - RGT 950T
Siemens Healthcare Diagnostics Inc.
11206268
In Commercial Distribution

  • 00630414293745 ()
11206268

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Prolactin (PRL) - Atellica IM - RGT 250
Siemens Healthcare Diagnostics Inc.
11206258
In Commercial Distribution

  • 00630414294223 ()
  • 00630414293721 ()
11206258

  • Prolactin IVD, kit, chemiluminescent immunoassay
Progesterone (PRGE) - Atellica IM - RGT 450T
Siemens Healthcare Diagnostics Inc.
11206257
In Commercial Distribution

  • 00630414294216 ()
  • 00630414293714 ()
11206257

  • Progesterone IVD, kit, chemiluminescent immunoassay
Luteinizing Hormone (LH) - Atellica IM - RGT - 550T
Siemens Healthcare Diagnostics Inc.
11206256
In Commercial Distribution

  • 00630414294209 ()
  • 00630414293707 ()
11206256

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
Insulin (IRI) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11206267
In Commercial Distribution

  • 00630414293691 ()
11206267

  • Insulin IVD, kit, chemiluminescent immunoassay
Free T4 (FT4) - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206255
In Commercial Distribution

  • 00630414294193 ()
  • 00630414293684 ()
11206255

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Free T3 (FT3) - Atellica IM - RGT 300T
Siemens Healthcare Diagnostics Inc.
11206254
In Commercial Distribution

  • 00630414294186 ()
  • 00630414293677 ()
11206254

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
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