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 ID: EABA40000261
• NIH Device Record Key: 224bae6a-b5d9-404d-a315-5803b8658fff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Piccolo Hepatic Function Panel
• Version Model Number: 400-0026
• Catalog Number: 400-0026
• Company DUNS: 555503770
• Company Name: ABAXIS, INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EABA40000260 [Unit of Use]
HIBCC	EABA40000261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934592

FDA Product Code

• CKF: Phenylphosphate, Alkaline Phosphatase Or Isoenzymes

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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