Piccolo Hepatic Function Panel 400-0026

GUDID EABA40000261

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.

ABAXIS, INC.

Total alkaline phosphatase (ALP) IVD, reagent
Primary Device IDEABA40000261
NIH Device Record Key224bae6a-b5d9-404d-a315-5803b8658fff
Commercial Distribution StatusIn Commercial Distribution
Brand NamePiccolo Hepatic Function Panel
Version Model Number400-0026
Catalog Number400-0026
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 Latextrue
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
HIBCCEABA40000260 [Unit of Use]
HIBCCEABA40000261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CKFPhenylphosphate, Alkaline Phosphatase Or Isoenzymes

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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