AccessGUDID - DEVICE: Piccolo Lipid Panel (EABA40000251)

GUDID

Device Identifier (DI) Information

Brand Name: Piccolo Lipid Panel
Version or Model: 400-0025
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 400-0025
Company Name: ABAXIS, INC.

Primary DI Number: EABA40000251
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 555503770 *Terms of Use

Device Description: The Piccolo® Lipid Panel reagent disc, 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), and triglycerides (TRIG) 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 these 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. This test is waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the test is 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 Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
52853	Glucose/ketone/lipid profile 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 to produce a profile consisting of one or multiple clinical chemistry analytes which may include glucose, ketones and/or a lipid profile.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JGY	Colorimetric Method, Triglycerides
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
CHH	Enzymatic Esterase--Oxidase, Cholesterol

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 36 and 46 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9c84ee62-30c3-45b8-95ec-075803aee681
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016