FDA.reportPublic FDA data

Piccolo General Chemistry 13

Primary DI
EABA40000291
Brand
Piccolo General Chemistry 13
Company
ABAXIS, INC.
Model
400-0029
Catalog number
400-0029
Device description
The Piccolo® General Chemistry 13 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 alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total bilirubin, total protein, blood urea nitrogen (BUN), and uric acid 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.
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
CIGDiazo Colorimetry, Bilirubin
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
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
CIGDiazo Colorimetry, BilirubinClinical 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
JQBKinetic Method, Gamma-Glutamyl TranspeptidaseClinical Chemistry1
KNKAcid, Uric, Uricase (Colorimetric)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EABA40000291PrimaryHIBCC0
EABA40000290Unit 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
+1 (510) 675 6500abaxis@abaxis.com
+496155780210abaxis@abaxis.de

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
EABA40000351Piccolo BioChemistry Panel Plus400-0035400-00352016-09-23
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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