Piccolo MetLyte 8 Panel 400-0023

GUDID EABA40000231

The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. 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 may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.

ABAXIS, INC.

Chloride (Cl-) IVD, reagent

• Primary Device ID: EABA40000231
• NIH Device Record Key: 11474676-58e3-4809-ad65-a3f4dabbffc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Piccolo MetLyte 8 Panel
• Version Model Number: 400-0023
• Catalog Number: 400-0023
• 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	EABA40000230 [Unit of Use]
HIBCC	EABA40000231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010670

FDA Product Code

• CHJ: Mercuric Thiocyanate, Colorimetry, Chloride

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

Devices Manufactured by ABAXIS, INC.

• EABA110000001 - Piccolo Xpress: 2018-07-06 The Piccolo Xpress chemistry analyzer provides quantitative in-vitro determinations of clinical chemistry analytes in lithium-he
• EABA11001511 - Piccolo Xpress Military Deployment Kit: 2018-07-06 The Piccolo Xpress chemistry analyzer provides quantitative in-vitro determinations of clinical chemistry analytes in lithium-he
• EABA40000221 - Piccolo Electrolyte Panel: 2018-07-06 The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is
• EABA40000231 - Piccolo MetLyte 8 Panel: 2018-07-06The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. 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 may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
• EABA40000231 - Piccolo MetLyte 8 Panel: 2018-07-06 The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is in
• EABA40000241 - Piccolo Basic Metabolic Panel: 2018-07-06 The Piccolo® Basic Metabolic Panel, used with the Piccolo blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, i
• EABA40000261 - Piccolo Hepatic Function Panel: 2018-07-06 The Piccolo® Hepatic Function Panel, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro
• EABA40000271 - Piccolo Renal Function Panel: 2018-07-06 The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer i
• EABA40000281 - Piccolo Comprehensive Metabolic Panel: 2018-07-06 The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry