DEVICE: Piccolo Basic Metabolic Panel Plus (EABA40000311)

Download: XML | JSON

Device Identifier (DI) Information

Piccolo Basic Metabolic Panel Plus
400-0031
400-0031
ABAXIS, INC.
EABA40000311
HIBCC
10
The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Total lactate dehydrogenase (LDH) 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 total lactate dehydrogenase (LDH) in a clinical specimen.
Magnesium (Mg2+) 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 magnesium (Mg2+) in a clinical specimen.
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.
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.
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.
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.
Calcium (Ca2+) 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 calcium (Ca2+) in a clinical specimen.
Blood Urea Nitrogen (BUN) 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 blood urea nitrogen (BUN) in a clinical specimen.
Creatinine 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 creatinine in a clinical specimen.
Glucose 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 glucose in a clinical specimen.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
JGJ Photometric Method, Magnesium
CHJ Mercuric Thiocyanate, Colorimetry, Chloride
JGS Electrode, Ion Specific, Sodium
KHS Enzymatic, Carbon-Dioxide
CEM Electrode, Ion Specific, Potassium
CJY Azo Dye, Calcium
CDN Urease, Photometric, Urea Nitrogen
CGX Alkaline Picrate, Colorimetry, Creatinine
CGA Glucose Oxidase, Glucose
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 36 and 46 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 23, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: EABA40000310 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
1-800-822-2947
Piccolo@abaxis.com
+49 6155780210
abaxis@abaxis.de
+1 (510) 675 6500
abaxis@abaxis.com
CLOSE