AccessGUDID - DEVICE: Piccolo Electrolyte Panel (EABA40000221)

GUDID

Device Identifier (DI) Information

Brand Name: Piccolo Electrolyte Panel
Version or Model: 400-0022
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 400-0022
Company Name: ABAXIS, INC.

Primary DI Number: EABA40000221
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 555503770 *Terms of Use

Device Description: The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, potassium, sodium, and total carbon dioxide 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
52879	Chloride (Cl-) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of chloride (Cl-) in a clinical specimen.	Active	false
52898	Sodium (Na+) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of sodium (Na+) in a clinical specimen.	Active	false
52873	Bicarbonate (HCO3-) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of bicarbonate (HCO3-) in a clinical specimen.	Obsolete	false
52895	Potassium (K+) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of potassium (K+) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CHJ	Mercuric Thiocyanate, Colorimetry, Chloride
JGS	Electrode, Ion Specific, Sodium
KHS	Enzymatic, Carbon-Dioxide
CEM	Electrode, Ion Specific, Potassium

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K010670	000
K992140	000
K993211	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 36 and 46 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e6e1353c-eea3-47be-88ae-42a0c5a5fb58
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016