Piccolo Hepatic Function Panel

Basic Information

• Brand Name: Piccolo Hepatic Function Panel
• Primary DI: EABA40000261
• Version / Model: 400-0026
• Catalog Number: 400-0026
• 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: 4
• Public Version Date: 2025-08-18
• Public Version Status: Update
• Public Device Record Key: 224bae6a-b5d9-404d-a315-5803b8658fff

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
CKF	Phenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	862.1050	2
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	862.1030	1
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	862.1035	2
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	862.1635	2
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	862.1110	2
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	862.1100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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
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
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
53236	Conjugated (direct) 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 conjugated (direct) bilirubin 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	EABA40000261	HIBCC
Unit of Use	EABA40000260	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K934592	000
K942782	000
K950164	000

Storage Conditions

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