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The Piccolo® General Chemistry 13 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), amylase, aspartate aminotransferase (AST), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total bilirubin, total protein, blood urea nitrogen (BUN), and uric acid 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.
400-0029
In Commercial Distribution
- EABA40000291 ()
- EABA40000290 ()
400-0029
- Total aspartate aminotransferase (AST) IVD, reagent
- Glucose IVD, reagent
- Total bilirubin IVD, reagent
- Total protein IVD, reagent
- Uric acid IVD, reagent
- Creatinine IVD, reagent
- Urea IVD, reagent
- Alanine aminotransferase (ALT) IVD, reagent
- Total alkaline phosphatase (ALP) IVD, reagent
- Total amylase IVD, reagent
- Calcium (Ca2+) IVD, reagent
- Gamma-glutamyltransferase (GGT) IVD, reagent
- Albumin IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
9251
In Commercial Distribution
- M52592510 ()
- Polyvalent human immunoglobulin antibody IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
9236
In Commercial Distribution
- M52592360 ()
- Polyvalent human immunoglobulin antibody IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
8JF52001
In Commercial Distribution
- M5258JF520010 ()
- Platelet aggregation analyser IVD
No Description
HELENA LABORATORIES CORPORATION
5770003
In Commercial Distribution
- M52557700030 ()
- Coagulation analyser IVD, laboratory
No Description
HELENA LABORATORIES CORPORATION
5770002
In Commercial Distribution
- M52557700020 ()
- Coagulation analyser IVD, laboratory
No Description
HELENA LABORATORIES CORPORATION
5770001
In Commercial Distribution
- M52557700010 ()
- Coagulation analyser IVD, laboratory
No Description
HELENA LABORATORIES CORPORATION
5755001
In Commercial Distribution
- M52557550010 ()
- Coagulation analyser IVD, laboratory
No Description
HELENA LABORATORIES CORPORATION
5755000
In Commercial Distribution
- M52557550000 ()
- Coagulation analyser IVD, laboratory
No Description
HELENA LABORATORIES CORPORATION
5753001
In Commercial Distribution
- M52557530010 ()
- Coagulation analyser IVD, laboratory