FDA.reportPublic FDA data

Piccolo BioChemistry Panel Plus

Primary DI
EABA40000351
Brand
Piccolo BioChemistry Panel Plus
Company
ABAXIS, INC.
Model
400-0035
Catalog number
400-0035
Device description
The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), c-reactive protein (CRP), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total protein, blood urea nitrogen (BUN), and uric acid 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.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDNUrease, Photometric, Urea Nitrogen
CEKBiuret (Colorimetric), Total Protein
CGAGlucose Oxidase, Glucose
CGXAlkaline Picrate, Colorimetry, Creatinine
CIJSaccharogenic, Amylase
CITNadh Oxidation/Nad Reduction, Ast/Sgot
CJWBromcresol Purple Dye-Binding, Albumin
CJYAzo Dye, Calcium
CKANadh Oxidation/Nad Reduction, Alt/Sgpt
CKFPhenylphosphate, Alkaline Phosphatase Or Isoenzymes
DCNSystem, Test, C-Reactive Protein
JQBKinetic Method, Gamma-Glutamyl Transpeptidase
KNKAcid, Uric, Uricase (Colorimetric)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDNUrease, Photometric, Urea NitrogenClinical Chemistry2
CEKBiuret (Colorimetric), Total ProteinClinical Chemistry2
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CGXAlkaline Picrate, Colorimetry, CreatinineClinical Chemistry2
CIJSaccharogenic, AmylaseClinical Chemistry2
CITNadh Oxidation/Nad Reduction, Ast/SgotClinical Chemistry2
CJWBromcresol Purple Dye-Binding, AlbuminClinical Chemistry2
CJYAzo Dye, CalciumClinical Chemistry2
CKANadh Oxidation/Nad Reduction, Alt/SgptClinical Chemistry1
CKFPhenylphosphate, Alkaline Phosphatase Or IsoenzymesClinical Chemistry2
DCNSystem, Test, C-Reactive ProteinImmunology2
JQBKinetic Method, Gamma-Glutamyl TranspeptidaseClinical Chemistry1
KNKAcid, Uric, Uricase (Colorimetric)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EABA40000351PrimaryHIBCC0
EABA40000350Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Total aspartate aminotransferase (AST) IVD, reagentA 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 aspartate aminotransferase (AST) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit46 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-822-2947Piccolo@abaxis.com
+496155780210abaxis@abaxis.de
+1 (510) 675 6500abaxis@abaxis.com

Regulatory Flags#

DUNS number
555503770
Device count
10
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EABA40000031Piccolo Liver Panel Plus400-0003400-00032016-09-23
EABA40000261Piccolo Hepatic Function Panel400-0026400-00262016-09-23
EABA40000271Piccolo Renal Function Panel400-0027400-00272016-09-23
EABA40000281Piccolo Comprehensive Metabolic Panel400-0028400-00282016-09-23
EABA40000291Piccolo General Chemistry 13400-0029400-00292016-09-23
EABA40000371Piccolo MetLac 12 Panel400-0037400-00372016-09-23
EABA40000411Piccolo AmLyte 13400-0041400-00412016-09-23
EABA110000001Piccolo Xpress1100-00001100-00002016-09-23
EABA11001511Piccolo Xpress Military Deployment Kit1100-15111100-15112017-06-30
EABA40000061Piccolo General Chemistry 6400-0006400-00062016-09-23
EABA40000231Piccolo MetLyte 8 Panel400-0023400-00232016-09-23
EABA40000241Piccolo Basic Metabolic Panel400-0024400-00242016-09-23
EABA40000311Piccolo Basic Metabolic Panel Plus400-0031400-00312016-09-23
EABA40000331Piccolo Kidney Check400-0033400-00332016-09-23
EABA40000341Piccolo MetLyte Plus CRP400-0034400-00342016-09-23
EABA40000221Piccolo Electrolyte Panel400-0022400-00222016-09-23
EABA40000251Piccolo Lipid Panel400-0025400-00252016-09-23
EABA40000301Piccolo Lipid Panel Plus400-0030400-00302016-09-23

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