SEARCH RESULTS FOR: (*Sandwhich Panel Machine*)(1496 results)
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® Hepatic Function Panel, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro
quantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, direct
bilirubin, total bilirubin, and total protein in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory
setting or point-of-care location.
ABAXIS, INC.
400-0026
In Commercial Distribution
- EABA40000261 ()
- EABA40000260 ()
400-0026
- Total alkaline phosphatase (ALP) IVD, reagent
- Alanine aminotransferase (ALT) IVD, reagent
- Conjugated (direct) bilirubin IVD, reagent
- Albumin IVD, reagent
- Total protein IVD, reagent
- Total bilirubin IVD, reagent
- Total aspartate aminotransferase (AST) 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
The Piccolo® Liver Panel Plus, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, utilizes dry and liquid reagents to provide in vitro quantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, gamma glutamyltransferase, total bilirubin, and total protein 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.
400-0003
In Commercial Distribution
- EABA40000031 ()
- EABA40000030 ()
400-0003
- Gamma-glutamyltransferase (GGT) IVD, reagent
- Total amylase IVD, reagent
- Total alkaline phosphatase (ALP) IVD, reagent
- Alanine aminotransferase (ALT) IVD, reagent
- Total protein IVD, reagent
- Total bilirubin IVD, reagent
- Total aspartate aminotransferase (AST) IVD, reagent
- Albumin IVD, reagent
The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in quality
control testing with the Accula™ Flu A / B Test.
MESA BIOTECH, INC.
FAB1100CW-C
In Commercial Distribution
- B540FAB1100CWC0 ()
FAB1100CW-1
- Thermal cycler nucleic acid amplification analyser IVD, point-of-care
The Accula™ Flu A / B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase
chain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A and
influenza B viral RNA. The Accula Flu A / B Test uses a nasal swab specimen collected from patients with signs and
symptoms of respiratory infection. Accula Flu A / B assay is intended as an aid in the diagnosis of influenza infections
in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza
C virus.
MESA BIOTECH, INC.
FAB1100CW
In Commercial Distribution
- B540FAB1100CW0 ()
FAB1100CW
- Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain
reaction (PCR) and lateral flow technologies for the qualitative, visual detection of respiratory syncytial virus (RSV) viral RNA.
The Silaris RSV Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection.
The Silaris RSV Test is intended as an aid in the diagnosis of RSV infection in children and adults in conjunction with clinical
and epidemiological risk factors.
MESA BIOTECH, INC.
1040
In Commercial Distribution
- B54010400 ()
1040
- Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)
The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris RSV Test
MESA BIOTECH, INC.
1029
In Commercial Distribution
- B54010290 ()
1029
- Respiratory syncytial virus (RSV) nucleic acid IVD, control