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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 Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 and Unicel DxC 600 Systems.
SENTINEL CH. SPA
A26849
In Commercial Distribution

  • 08058056681263 ()

  • Total Volume: 120 Milliliter
A26849

  • Kappa/lambda light chain immunoglobulin IVD, reagent
The kit is intended for the quantitative determination of ceruloplasmin (CER) in serum and plasma by immunoturbidimetry. For in vitro diagnostic use only.
SENTINEL CH. SPA
A26842
In Commercial Distribution

  • 08058056681232 ()

  • Total Volume: 108 Milliliter
A26842

  • Ceruloplasmin IVD, reagent
The Kappa light chains assay is an in vitro diagnostic test used for the quantitative determination of immunoglobulin bound and free kappa light chains (KAPPA) in serum and in Li-heparin plasma by immunoturbidimetry on Synchron LX20 and Unicel DxC 600 Systems.
SENTINEL CH. SPA
A26845
In Commercial Distribution

  • 08058056681157 ()

  • Total Volume: 120 Milliliter
A26845

  • Kappa/lambda light chain immunoglobulin IVD, reagent
The Ceruloplasmin assay is to be used for the quantitative immunoturbidimetric determination of ceruloplasmin in serum and plasma. The assay is intended for professional use only. For In Vitro diagnostic use.
SENTINEL CH. SPA
11065N
In Commercial Distribution

  • 08058056680730 ()

  • Total Volume: 108 Milliliter
11065N

  • Ceruloplasmin IVD, reagent
The Cholinesterase Liquid is an In Vitro Diagnostic test used for the determination of the cholinesterase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only.
SENTINEL CH. SPA
17019H
In Commercial Distribution

  • 08058056680709 ()

  • Total Volume: 120 Milliliter
17019H

  • Pseudocholinesterase IVD, reagent
The kit is intended for the quantitative determination of Alpha 1-Acid Glycoprotein (AGP) in serum and plasma by immunoturbidimetry. For In Vitro Diagnostic Use only.
SENTINEL CH. SPA
A26838
In Commercial Distribution

  • 08058056680648 ()

  • Total Volume: 88 Milliliter
A26838

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, reagent
The Lipase Color Liquid is an In Vitro Diagnostic test used for the determination of the lipase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only.
SENTINEL CH. SPA
17401B
In Commercial Distribution

  • 08058056680617 ()

  • Total Volume: 49 Milliliter
17401B

  • Lipase IVD, kit, spectrophotometry
The Pancreatic Amylase assay is an in vitro diagnostic test used for the determination on AU480, AU680 and AU5800 automatic analyzers of the pancreatic amylase in serum and plasma by enzymatic colorimetric method. The assay is intended for professional use only.
SENTINEL CH. SPA
A53704
In Commercial Distribution

  • 08058056680587 ()

  • Total Volume: 102 Milliliter
A53704

  • Amylase isoenzyme IVD, reagent
Plasmaproteins Cal 3x must be used only for the calibration of the plasmaproteins tests with immunoturbidimetric method. Use the Calibrator according to the indicated analytical procedure. For professional use only. For in vitro diagnostics use
SENTINEL CH. SPA
11206D
In Commercial Distribution

  • 08058056680532 ()

  • Total Volume: 4 Milliliter
11206D

  • Plasma protein IVD, calibrator
Lp(a) Cal Set should be used as calibration curve for the Lp(a) Ultra test. Use the Calibrator according to the indicated analytical procedure.
SENTINEL CH. SPA
11522D
In Commercial Distribution

  • 08058056680228 ()
11522D

  • Lipoprotein A IVD, calibrator
The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation. For In Vitro Diagnostic use.
SENTINEL CH. SPA
11504D
In Commercial Distribution

  • 08058056680211 ()
11504D

  • Lipoprotein A IVD, reagent
Immuno Control Set 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 professional use only. For In Vitro diagnostic use.
SENTINEL CH. SPA
11211A
In Commercial Distribution

  • 08058056680204 ()

  • Total Volume: 4 Milliliter
11211A

  • Plasma protein IVD, control
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
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