Piccolo Lipid Panel Plus - The Piccolo® Lipid Panel Plus, used with the - ABAXIS, INC.

Duns Number:555503770

Device Description: The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer or the Picc

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More Product Details

Catalog Number

400-0030

Brand Name

Piccolo Lipid Panel Plus

Version/Model Number

400-0030

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Device Record Status

Public Device Record Key

c8f6bf8c-7451-4c6c-ab23-e7063c80f920

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABAXIS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2