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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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No Description
Roche Diagnostics GmbH
3607402190
In Commercial Distribution

  • 04015630997237 ()
3607402190

  • Bicarbonate (HCO3-) IVD, kit, enzyme spectrophotometry
No Description
Roche Diagnostics GmbH
5446376191
In Commercial Distribution

  • 04015630935673 ()
5446376191

  • Bicarbonate (HCO3-) IVD, kit, enzyme spectrophotometry
No Description
Roche Diagnostics GmbH
3333825190
In Commercial Distribution

  • 04015630919536 ()
3333825190

  • Total protein IVD, kit, enzyme spectrophotometry
No Description
Roche Diagnostics GmbH
3183734190
In Commercial Distribution

  • 04015630918928 ()
3183734190

  • Total protein IVD, kit, enzyme spectrophotometry
QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red (Pyrogallol Red method) Total Protein Assay System. The standards are used to establish curves and to calibrate manual and automated methods for cerebrospinal fluid and urine total protein assays. Four protein standard concentrations are available: 25, 50, 100, and 200 mg/dl.
QUANTIMETRIX CORPORATION
3410-02
In Commercial Distribution

  • M0513410021 ()
3410-02

  • Total protein IVD, kit, enzyme spectrophotometry
The quanTtest red Total Protein Assay System is intended for the quantitative determination of protein in cerebrospinal fluid and urine for both manual and automated systems. The quanTtest red Total Protein Assay System provides a simple method of protein quantitation using microliter samples of urine or cerebrospinal fluid. Total Protein is measured by the dye binding method using a complex of pyrogallol red and molybdenum acid (Mo+6). At low pH the dye is red and changes to blue when complexed with protein.The kit consists of reagent, controls for both CSF and urine chemistry, and four reagent standards: Level 2 (25 mg/dL), Level 3 (50 mg/dL), Level 4 (100 mg/dL), and Level 5 (200 mg/dL).
QUANTIMETRIX CORPORATION
2210-02
In Commercial Distribution

  • M0512210021 ()
2210-02

  • Total protein IVD, kit, enzyme spectrophotometry
No Description
Medicalsystem Biotechnology Co., Ltd.
None
In Commercial Distribution

  • 06970291985208 ()


  • Total protein IVD, kit, enzyme spectrophotometry
No Description
Medicalsystem Biotechnology Co., Ltd.
None
In Commercial Distribution

  • 06970291985192 ()


  • Total protein IVD, kit, enzyme spectrophotometry
Bicarbonate
Beckman Coulter, Inc.
OSR6637
In Commercial Distribution

  • 15099590060206 ()


  • Bicarbonate (HCO3-) IVD, kit, enzyme spectrophotometry
Bicarbonate
Beckman Coulter, Inc.
OSR6137
In Commercial Distribution

  • 15099590010348 ()


  • Bicarbonate (HCO3-) IVD, kit, enzyme spectrophotometry
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