ABAXIS, INC.

Address:3240 WHIPPLE RD.,UNION CITY,CA,94587,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Urease, Photometric, Urea Nitrogen (CDN) (8) Alkaline Picrate, Colorimetry, Creatinine (CGX) (8) Glucose Oxidase, Glucose (CGA) (8) Azo Dye, Calcium (CJY) (6) Nadh Oxidation/Nad Reduction, Alt/Sgpt (CKA) (5) Bromcresol Purple Dye-Binding, Albumin (CJW) (5) Nadh Oxidation/Nad Reduction, Ast/Sgot (CIT) (5) Electrode, Ion Specific, Potassium (CEM) (5) Electrode, Ion Specific, Sodium (JGS) (5) Enzymatic, Carbon-Dioxide (KHS) (4) Mercuric Thiocyanate, Colorimetry, Chloride (CHJ) (4) Saccharogenic, Amylase (CIJ) (3) Biuret (Colorimetric), Total Protein (CEK) (3) Phenylphosphate, Alkaline Phosphatase Or Isoenzymes (CKF) (3) System, Test, C-Reactive Protein (DCN) (3) Diazo Colorimetry, Bilirubin (CIG) (3) Kinetic Method, Gamma-Glutamyl Transpeptidase (JQB) (2) Atp And Creatine Kinase (Enzymatic), Creatine (JLB) (2) Photometric Method, Magnesium (JGJ) (2) Acid, Uric, Uricase (Colorimetric) (KNK) (2) Acid, Lactic, Enzymatic Method (KHP) (1) Phosphomolybdate (Colorimetric), Inorganic Phosphorus (CEO) (1) Colorimetric Method, Triglycerides (JGY) (1) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (1) Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase (CFJ) (1) Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl (LBS) (1)

Premarket Exempt

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Piccolo Comprehensive Metabolic Panel - EABA40000281 Catalog Number : 400-0028

Device Description : The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemist 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.

Device Class :

Duns Number: 555503770

Premarket Exempt : No

Product Code : CHJ, CIT, CGA, CIG, CEK, CJW, CGX, CDN, CKA, CKF, CJY, CEM, KHS, JGS

Prescription Use : No

Device Count : 10

Piccolo General Chemistry 13 - EABA40000291 Catalog Number : 400-0029

Device Description : The Piccolo® General Chemistry 13 used with the Piccolo blood chemistry analyzer 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.

Device Class :

Duns Number: 555503770

Premarket Exempt : No

Product Code : CIT, CGA, CIG, CEK, KNK, CJW, CGX, CDN, CKA, CKF, CIJ, CJY, JQB

Prescription Use : No

Device Count : 10

Piccolo Lipid Panel Plus - EABA40000301 Catalog Number : 400-0030

Device Description : The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer o 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.

Device Class :

Duns Number: 555503770

Premarket Exempt : No

Product Code : JGY, LBS, CHH, CKA, CGA, CIT

Prescription Use : No

Device Count : 10

Piccolo Basic Metabolic Panel Plus - EABA40000311 Catalog Number : 400-0031

Device Description : The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry a 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.

Device Class :

Duns Number: 555503770

Premarket Exempt : No

Product Code : CFJ, JGJ, CHJ, JGS, KHS, CEM, CJY, CDN, CGX, CGA

Prescription Use : No

Device Count : 10

Piccolo Kidney Check - EABA40000331 Catalog Number : 400-0033

Device Description : The Piccolo® Kidney Check , used with the Piccolo Xpress chemistry analyzer, is The Piccolo® Kidney Check , used with the Piccolo Xpress chemistry analyzer, is intended to be used for the in vitro quantitative determination of creatinine 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.

Device Class :

Duns Number: 555503770

Premarket Exempt : No

Product Code : CDN, CGX

Prescription Use : No

Device Count : 10

Piccolo MetLyte Plus CRP - EABA40000341 Catalog Number : 400-0034

Device Description : The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemis 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.

Device Class :

Duns Number: 555503770

Premarket Exempt : No

Product Code : DCN, CHJ, JGS, KHS, CEM, JLB, CDN, CGX, CGA

Prescription Use : No

Device Count : 10

Piccolo BioChemistry Panel Plus - EABA40000351 Catalog Number : 400-0035

Device Description : The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry an The Piccolo® BioChemistry Panel Plus, used with 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), c-reactive protein (CRP), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total protein, blood urea nitrogen (BUN), and uric acid 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.

Device Class :

Duns Number: 555503770

Premarket Exempt : No

Product Code : CIT, CGA, CEK, KNK, CJW, CGX, CDN, CKA, CKF, CIJ, CJY, JQB, DCN

Prescription Use : No

Device Count : 10

Piccolo MetLac 12 Panel - EABA40000371 Catalog Number : 400-0037

Device Description : The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemist 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.

Device Class :

Duns Number: 555503770

Premarket Exempt : No

Product Code : KHP, JGJ, CEO, CHJ, JGS, KHS, CEM, CJY, CDN, CGX, CJW, CGA

Prescription Use : No

Device Count : 10

Piccolo AmLyte 13 - EABA40000411 Catalog Number : 400-0041

Device Description : The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is in The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, amylase, aspartate aminotransferase (AST), calcium, c-reactive protein (CRP), creatine kinase, creatinine, glucose, potassium, sodium, total bilirubin 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.

Device Class :

Duns Number: 555503770

Premarket Exempt : No

Product Code : CIT, CGA, CIG, CJW, CGX, CDN, CKA, CIJ, CJY, JLB, CEM, JGS, DCN

Prescription Use : No

Device Count : 10

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