Piccolo Lipid Panel Plus 400-0030

GUDID EABA40000301

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.

ABAXIS, INC.

Glucose/ketone/lipid profile IVD, reagent
Primary Device IDEABA40000301
NIH Device Record Keyc8f6bf8c-7451-4c6c-ab23-e7063c80f920
Commercial Distribution StatusIn Commercial Distribution
Brand NamePiccolo Lipid Panel Plus
Version Model Number400-0030
Catalog Number400-0030
Company DUNS555503770
Company NameABAXIS, INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-822-2947
EmailPiccolo@abaxis.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEABA40000300 [Unit of Use]
HIBCCEABA40000301 [Primary]

FDA Product Code

JGYColorimetric Method, Triglycerides

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

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