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COLORADO THERAPEUTICS LLC
XI-S+
In Commercial Distribution
- 00868623000308 ()
- Height: 6 Centimeter
- Length: 6 Centimeter
XI0606-S+
- Abdominal hernia surgical mesh, collagen, antimicrobial
Natural Elegance Universal Bond
HENRY SCHEIN, INC.
1126719
In Commercial Distribution
- 10304040007096 ()
- Total Volume: 0.125 Milliliter
- Microbrush x 50
- Single Use Predosed Tips x 50
1126719
- Dentine adhesive
The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location.
ABAXIS, INC.
400-0037
In Commercial Distribution
- EABA40000371 ()
- EABA40000370 ()
400-0037
- Lactate IVD, reagent
- Magnesium (Mg2+) IVD, reagent
- 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® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of c-reactive protein (CRP), chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement.
ABAXIS, INC.
400-0034
In Commercial Distribution
- EABA40000341 ()
- EABA40000340 ()
400-0034
- C-reactive protein (CRP) IVD, reagent
- 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
The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only.
ABAXIS, INC.
400-0031
In Commercial Distribution
- EABA40000311 ()
- EABA40000310 ()
400-0031
- Total lactate dehydrogenase (LDH) IVD, reagent
- Magnesium (Mg2+) 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
- Glucose IVD, reagent
The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), triglycerides (TRIG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and glucose (GLU) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From the CHOL, HDL and TRIG determinations, low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer.
Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders.
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 (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0030
In Commercial Distribution
- EABA40000301 ()
- EABA40000300 ()
400-0030
- Glucose/ketone/lipid profile IVD, reagent
- Alanine aminotransferase (ALT) IVD, reagent
- Glucose IVD, reagent
- Total aspartate aminotransferase (AST) IVD, reagent
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® Lipid Panel reagent disc, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® Chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), and triglycerides (TRIG) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From these determinations low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer.
Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders.
This test is waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the test is considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0025
In Commercial Distribution
- EABA40000251 ()
- EABA40000250 ()
400-0025
- Glucose/ketone/lipid profile 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