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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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The Ammonia Ultra assay is intended for the in vitro quantitative enzymatic determination of ammonia in human plasma using an automated analyzer. Measurements of ammonia are used to aid in the diagnosis of patients suspected of having hyperammonemia. For laboratory professional use only.
SENTINEL CH. SPA
17660
In Commercial Distribution

  • 08058056680181 ()
17660

  • Ammonia IVD, kit, spectrophotometry
Clin Chem Cal must be used only for the calibration of clinical chemistry tests. For in vitro diagnostic use only.
SENTINEL CH. SPA
16550
In Commercial Distribution

  • 08058056680136 ()

  • Total Volume: 12 Milliliter
16550

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Clin Chem Control 2 is for use in quality control by monitoring accuracy and precision for the quantitative method as specified in the assigned concentration Table. Use the Control Material like the specimens, according to the indicated analytical procedure. For In Vitro Diagnostic use.
SENTINEL CH. SPA
16250
In Commercial Distribution

  • 08058056680105 ()

  • Total Volume: 30 Milliliter
16250

  • Multiple-type clinical chemistry analyte profile IVD, control
Clin Chem Control 1 is for use in quality control by monitoring accuracy and precision for the quantitative method as specified in the assigned concentration Table. Use the Control Material like the specimens, according to the indicated analytical procedure. For In Vitro Diagnostic use.
SENTINEL CH. SPA
16150
In Commercial Distribution

  • 08058056680099 ()

  • Total Volume: 30 Milliliter
16150

  • Multiple-type clinical chemistry analyte profile IVD, control
HbA1c Advanced
BECKMAN COULTER IRELAND INC.
B93009
In Commercial Distribution

  • 15099590012120 ()


  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry
Latex immunoassay for the determination of the C-Reactive Protein (CRP) concentration in serum and plasma on VITROS® 4600 Chemistry System and VITROS® 5600 Integrated System. The assay is intended for professional use only. For In Vitro diagnostic use only.
SENTINEL CH. SPA
115646
In Commercial Distribution

  • 08058056681911 ()

  • Total Volume: 104 Milliliter
115646

  • C-reactive protein (CRP) IVD, reagent
Wound Matrix
REPRISE BIOMEDICAL, INC.
3000
In Commercial Distribution

  • 00857072005316 ()

  • Length: 2 Centimeter
  • Width: 2 Centimeter
  • Height: 2 Centimeter


  • Collagen wound matrix dressing
Darkroom automated x-ray film processor
PROTEC GmbH & Co. KG
1190
In Commercial Distribution

  • 04260502640005 ()
1190-2-1000

  • Darkroom automated x-ray film processor
No Description
TOKYO BOEKI MEDISYS INC.
30-27-0905
In Commercial Distribution

  • 04580262040076 ()
30-27-0905

  • Multiple electrolyte IVD, calibrator
No Description
TOKYO BOEKI MEDISYS INC.
20-27-0478
In Commercial Distribution

  • 04580262010314 ()
20-27-0478

  • Multiple electrolyte IVD, calibrator
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