Piccolo General Chemistry 13

Basic Information

• Brand Name: Piccolo General Chemistry 13
• Primary DI: EABA40000291
• Version / Model: 400-0029
• Catalog Number: 400-0029
• Company Name: ABAXIS, INC.
• Labeler DUNS: 555503770
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2025-08-18
• Public Version Status: Update
• Public Device Record Key: 6974d4f7-b8df-444f-b3ac-e41b4edb5ded

Device Description

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 Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	862.1100	2
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	862.1110	2
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	862.1635	2
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	862.1775	1
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	862.1035	2
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	862.1225	2
CDN	Urease, Photometric, Urea Nitrogen	Clinical Chemistry	862.1770	2
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	862.1030	1
CKF	Phenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	862.1050	2
CIJ	Saccharogenic, Amylase	Clinical Chemistry	862.1070	2
CJY	Azo Dye, Calcium	Clinical Chemistry	862.1145	2
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	862.1360	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52875	Calcium (Ca2+) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of calcium (Ca2+) in a clinical specimen.	No	Active
52925	Alanine aminotransferase (ALT) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of alanine aminotransferase (ALT) in a clinical specimen.	No	Active
52929	Total alkaline phosphatase (ALP) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total alkaline phosphatase (ALP) in a clinical specimen.	No	Active
52941	Total amylase IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total amylase in a clinical specimen.	No	Active
52955	Total aspartate aminotransferase (AST) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total aspartate aminotransferase (AST) in a clinical specimen.	No	Active
53030	Gamma-glutamyltransferase (GGT) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of gamma glutamyltransferase (GGT) in a clinical specimen.	No	Active
53231	Total bilirubin IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total bilirubin in a clinical specimen.	No	Active
53252	Creatinine IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of creatinine in a clinical specimen.	No	Active
53307	Glucose IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.	No	Active
53586	Uric acid IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of uric acid in a clinical specimen.	No	Active
53590	Urea IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.	No	Active
53599	Albumin IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of albumin in a clinical specimen.	No	Active
53989	Total protein IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total protein in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EABA40000291	HIBCC
Unit of Use	EABA40000290	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 36 – 46 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius