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 Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0028
In Commercial Distribution

  • EABA40000281 ()
  • EABA40000280 ()
400-0028

  • Chloride (Cl-) IVD, reagent
  • Total aspartate aminotransferase (AST) IVD, reagent
  • Glucose IVD, reagent
  • Total bilirubin IVD, reagent
  • Total protein IVD, reagent
  • Albumin IVD, reagent
  • Creatinine IVD, reagent
  • Urea IVD, reagent
  • Alanine aminotransferase (ALT) IVD, reagent
  • Total alkaline phosphatase (ALP) IVD, reagent
  • Calcium (Ca2+) IVD, reagent
  • Potassium (K+) IVD, reagent
  • Bicarbonate (HCO3-) IVD, reagent
  • Sodium (Na+) IVD, control
The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0027
In Commercial Distribution

  • EABA40000271 ()
  • EABA40000270 ()
400-0027

  • Inorganic phosphate (PO43-) IVD, reagent
  • Chloride (Cl-) IVD, reagent
  • Sodium (Na+) IVD, control
  • Bicarbonate (HCO3-) IVD, reagent
  • Potassium (K+) IVD, reagent
  • Calcium (Ca2+) IVD, reagent
  • Urea IVD, reagent
  • Creatinine IVD, reagent
  • Albumin IVD, reagent
  • Glucose IVD, reagent
The Piccolo® Basic Metabolic Panel, used with the Piccolo blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, potassium, sodium, total carbon dioxide, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0024
In Commercial Distribution

  • EABA40000241 ()
  • EABA40000240 ()
400-0024

  • Chloride (Cl-) IVD, reagent
  • Sodium (Na+) IVD, control
  • Bicarbonate (HCO3-) IVD, reagent
  • Potassium (K+) IVD, reagent
  • Calcium (Ca2+) IVD, reagent
  • Urea IVD, reagent
  • Creatinine IVD, reagent
  • Glucose IVD, reagent
The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0023
In Commercial Distribution

  • EABA40000231 ()
  • EABA40000230 ()
400-0023

  • Chloride (Cl-) IVD, reagent
  • Sodium (Na+) IVD, control
  • Bicarbonate (HCO3-) IVD, reagent
  • Potassium (K+) IVD, reagent
  • Total creatine kinase (CK) IVD, reagent
  • Urea IVD, reagent
  • Creatinine IVD, reagent
  • Glucose IVD, reagent
eSensor® Respiratory Viral Panel Reagent (RVP) (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Respiratory Viral Panel (RVP)
Not in Commercial Distribution

  • 00857167005139 ()
MT005101

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
eSensor® Respiratory Viral Panel Amplification Reagents (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Respiratory Viral Panel (RVP)
Not in Commercial Distribution

  • 00857167005115 ()
MT005101

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
eSensor® Respiratory Viral Panel Cartridges (RVP) (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Respiratory Viral Panel (RVP)
Not in Commercial Distribution

  • 00857167005108 ()
MT005100

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
COMPACT CART W/ ARM SYS. FOR FLAT PANEL
PENTAX OF AMERICA, INC.
80242
In Commercial Distribution

  • 04961333241095 ()

  • Depth: 24.6 Inch
  • Width: 24.0 Inch
  • Height: 37.5 Inch


  • Endoscope transport trolley
PANEL DRAPE W/ADHESIVE 30 X 24, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 30748426068969 ()
  • 00748426068968 ()
  • 50748426068963 ()


  • Instrument/equipment drape, single-use, sterile
PANEL DRAPE W/ADHESIVE 30 X 24, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 30748426025269 ()
  • 00748426025268 ()
  • 50748426025263 ()


  • Instrument/equipment drape, single-use, sterile
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