AccessGUDID - DEVICE: Piccolo Lipid Panel Plus (EABA40000301)

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Device Identifier (DI) Information

Brand Name: Piccolo Lipid Panel Plus
Version or Model: 400-0030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 400-0030
Company Name: ABAXIS, INC.

Primary DI Number: EABA40000301
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 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.

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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, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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.	Active	false
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.	Active	false
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.	Active	false

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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
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt
CGA	Glucose Oxidase, Glucose
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot

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FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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Storage and Handling

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

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Clinically Relevant Size

Size Type Text
No Device Sizes

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Device Record Status

Public Device Record Key: c8f6bf8c-7451-4c6c-ab23-e7063c80f920
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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Secondary DI

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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Unit of Use DI

Unit of Use DI Number: EABA40000300 CLOSE

Direct Marking (DM)

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
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Production Identifier(s) in UDI

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

Phone: 1-800-822-2947
Email: Piccolo@abaxis.com

Phone: +496155780210
Email: abaxis@abaxis.de

Phone: +1 (510) 675 6500
Email: abaxis@abaxis.com

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