Piccolo MetLyte 8 Panel - The Piccolo® MetLyte 8 Panel, used with the - ABAXIS, INC.

Duns Number:555503770

Device Description: The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or the Picco 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.

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More Product Details

Catalog Number

400-0023

Brand Name

Piccolo MetLyte 8 Panel

Version/Model Number

400-0023

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

K993211,K992140,K942782,K934592,K010670,K993211,K992140,K942782,K934592,K010670

Product Code Details

Product Code

CDN

Product Code Name

Urease, Photometric, Urea Nitrogen

Device Record Status

Public Device Record Key

11474676-58e3-4809-ad65-a3f4dabbffc5

Public Version Date

July 06, 2018

Public Version Number

4

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