Piccolo MetLyte Plus CRP 400-0034

GUDID EABA40000341

The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of c-reactive protein (CRP), chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) 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.

C-reactive protein (CRP) IVD, reagent

• Primary Device ID: EABA40000341
• NIH Device Record Key: 3015c06d-d980-4781-a503-a1f2450ea422
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Piccolo MetLyte Plus CRP
• Version Model Number: 400-0034
• Catalog Number: 400-0034
• 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	EABA40000340 [Unit of Use]
HIBCC	EABA40000341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010670

FDA Product Code

• DCN: System, Test, C-Reactive Protein

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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