Piccolo BioChemistry Panel Plus 400-0035

GUDID EABA40000351

The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), c-reactive protein (CRP), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total protein, blood urea nitrogen (BUN), and uric acid in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement.

ABAXIS, INC.

Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent Total aspartate aminotransferase (AST) IVD, reagent

• Primary Device ID: EABA40000351
• NIH Device Record Key: f2d0d500-ff43-4b3e-9362-6e7eab72ae28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Piccolo BioChemistry Panel Plus
• Version Model Number: 400-0035
• Catalog Number: 400-0035
• 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: false
• 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
• Phone: 1-800-822-2947
• Email: Piccolo@abaxis.com
• Phone: 1-800-822-2947
• Email: Piccolo@abaxis.com
• Phone: 1-800-822-2947
• Email: Piccolo@abaxis.com
• Phone: 1-800-822-2947
• Email: Piccolo@abaxis.com
• Phone: 1-800-822-2947
• Email: Piccolo@abaxis.com
• Phone: 1-800-822-2947
• Email: Piccolo@abaxis.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EABA40000350 [Unit of Use]
HIBCC	EABA40000351 [Primary]

FDA Product Code

• CIT: Nadh Oxidation/Nad Reduction, Ast/Sgot

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: 2018-04-17
• Device Publish Date: 2016-09-23

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