SEARCH RESULTS FOR: (*Sandwhich Panel Machine*)(8542 results)
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
One Step Drug Screen Test Card (COC300/AMP1000/mAMP1000/MOP300)
ALERE SAN DIEGO, INC.
DOA-144-1351
In Commercial Distribution
- 10815845021083 ()
4588760099
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
9800066355000
In Commercial Distribution
- 04034089053752 ()
- Assistive pushchair
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0127
Not in Commercial Distribution
- 00815381020093 ()
RFIT-ASY-0127
- Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0126
Not in Commercial Distribution
- 00815381020086 ()
RFIT-ASY-0126
- Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
No Description
Aktina Corp.
51-250
In Commercial Distribution
- B365512500 ()
- Indexed-immobilization patient positioning system
No Description
Aktina Corp.
11-217
In Commercial Distribution
- B365112170 ()
- Radiological whole-body positioner