Piccolo MetLac 12 Panel 400-0037

GUDID EABA40000371

The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location.

ABAXIS, INC.

Lactate IVD, reagent

• Primary Device ID: EABA40000371
• NIH Device Record Key: 6c2ced0e-e535-4db2-8ab2-0f9dd0bd3839
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Piccolo MetLac 12 Panel
• Version Model Number: 400-0037
• Catalog Number: 400-0037
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EABA40000370 [Unit of Use]
HIBCC	EABA40000371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010670

FDA Product Code

• KHP: Acid, Lactic, Enzymatic Method

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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