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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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Estradiol - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10491445
In Commercial Distribution

  • 00630414574646 ()
10491445

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following inurine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).
Siemens Healthcare Diagnostics Inc.
10379675
In Commercial Distribution

  • 00630414574639 ()
10379675

  • Urine analyser IVD, point-of-care
ADVIA® CENTAUR® XP Instrument
Siemens Healthcare Diagnostics Inc.
10364455
In Commercial Distribution

  • 00630414573564 ()
078-A011-03

  • Chemiluminescent immunoassay analyser IVD
Estradiol - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10490889
In Commercial Distribution

  • 00630414573342 ()
10490889

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following inurine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).
Siemens Healthcare Diagnostics Inc.
10379677
In Commercial Distribution

  • 00630414572314 ()
10379677

  • Urine analyser IVD, point-of-care
NA+/K+/CA++/CL- Electrode fill solution. In vitro diagnostics material for use with RAPIDLab® 1200 electrodes.
Siemens Healthcare Diagnostics Inc.
10376882
In Commercial Distribution

  • 00630414570501 ()
  • 00630414010243 ()
10376882

  • Ion selective electrode (ISE) reference solution IVD, reagent
Methadone - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378762
In Commercial Distribution

  • 00630414568782 ()
10378762

  • Methadone IVD, kit, enzyme immunoassay (EIA)
Benzodiazepines - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378760
In Commercial Distribution

  • 00630414568768 ()
10378760

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
RAPIDPOINT® 350 Sensor Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 350 analyzer
Siemens Healthcare Diagnostics Inc.
10375812
In Commercial Distribution

  • 00630414566337 ()
10375812

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
RAPIDPOINT® 340 Reagent Module, pH / pCO2 / pO2, for use with Rapidpoint 340 analyzers
Siemens Healthcare Diagnostics Inc.
10375807
In Commercial Distribution

  • 00630414566306 ()
10375807

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
RAPIDPOINT® 350 Reagent Module pH / pCO2 / pO2 / Na+ / K+ / Cl- / Ca++ for use with Rapidpoint 350 analyzers
Siemens Healthcare Diagnostics Inc.
10375806
In Commercial Distribution

  • 00630414566290 ()
10375806

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
Capillary Tube Kit, for use with RapidPoint® 340/350 analyzers; contents: 2 vials (100 each) capillary tubes, 1 bag (500) end caps
Siemens Healthcare Diagnostics Inc.
10375804
In Commercial Distribution

  • 00630414566283 ()
10375804

  • Capillary blood collection tube IVD, lithium heparin
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)
TSH3-UL Master Curve Material Set - CENTAUR - CAL
Siemens Healthcare Diagnostics Inc.
10285735
In Commercial Distribution

  • 00630414565668 ()
4782400

  • Thyroid stimulating hormone (TSH) IVD, control
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
ADVIA® Autoslide Slide Maker Stainer
Siemens Healthcare Diagnostics Inc.
10282177
In Commercial Distribution

  • 00630414560595 ()
085-A001-02

  • Microscope slide maker/stainer IVD
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
Thyroid (6PK) (Ref) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10285905
In Commercial Distribution

  • 00630414555331 ()
4800840

  • Multiple human hormone IVD, calibrator
Thyroid (6PK) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10285904
In Commercial Distribution

  • 00630414555324 ()
4800735

  • Multiple human hormone IVD, calibrator
Thyroid (2PK) - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10285903
In Commercial Distribution

  • 00630414555317 ()
4800646

  • Multiple human hormone IVD, calibrator
SHBG - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10283087
Not in Commercial Distribution

  • 00630414551548 ()
6520781

  • Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay
SHBG Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10283086
Not in Commercial Distribution

  • 00630414551531 ()
6520773

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, glucose, ketone (acetoacetic acid), pH, bilirubin and urobilinogen.
Siemens Healthcare Diagnostics Inc.
10339953
In Commercial Distribution

  • 00630414551111 ()
  • 00630414009735 ()
A2179B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Methadone Metabolic - ADVIA Chem. - CAL - 1x10mL
Siemens Healthcare Diagnostics Inc.
10283006
Not in Commercial Distribution

  • 00630414550954 ()
6520080

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator
Multi-Drug Urine Kit - ADVIA Chem. - CONS - 3x2x5mL
Siemens Healthcare Diagnostics Inc.
10282987
Not in Commercial Distribution

  • 00630414550916 ()
6520064

  • Multiple therapeutic drugs/drugs of abuse IVD, control
Siemens Healthcare Diagnostics MULTISTIX PRO® 10LS Reagent Strips for Urinalysis include test pads for protein-high, protein-low, creatinine, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, and specific gravity.
Siemens Healthcare Diagnostics Inc.
10332782
In Commercial Distribution

  • 00630414549262 ()
  • 00630414009643 ()
A1566C16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Siemens Healthcare Diagnostics MULTISTIX PRO® 10LS Reagent Strips for Urinalysis include test pads for protein-high, protein-low, creatinine, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, and specific gravity.
Siemens Healthcare Diagnostics Inc.
10331147
In Commercial Distribution

  • 00630414549255 ()
  • 00630414009636 ()
A1554C16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, glucose, ketone (aceto-acetic acietic acid) and pH
Siemens Healthcare Diagnostics Inc.
10337069
In Commercial Distribution

  • 00630414549101 ()
  • 00630414009674 ()
A2181B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid) and pH.
Siemens Healthcare Diagnostics Inc.
10326145
In Commercial Distribution

  • 00630414549040 ()
  • 00630414009582 ()
A2165C16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
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