FDA.reportPublic FDA data

Piccolo Basic Metabolic Panel Plus

Primary DI
EABA40000311
Brand
Piccolo Basic Metabolic Panel Plus
Company
ABAXIS, INC.
Model
400-0031
Catalog number
400-0031
Device description
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.
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
CEMElectrode, Ion Specific, Potassium
CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
CGAGlucose Oxidase, Glucose
CGXAlkaline Picrate, Colorimetry, Creatinine
CHJMercuric Thiocyanate, Colorimetry, Chloride
CJYAzo Dye, Calcium
JGJPhotometric Method, Magnesium
JGSElectrode, Ion Specific, Sodium
KHSEnzymatic, Carbon-Dioxide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDNUrease, Photometric, Urea NitrogenClinical Chemistry2
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CFJNad Reduction/Nadh Oxidation, Lactate DehydrogenaseClinical Chemistry2
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CGXAlkaline Picrate, Colorimetry, CreatinineClinical Chemistry2
CHJMercuric Thiocyanate, Colorimetry, ChlorideClinical Chemistry2
CJYAzo Dye, CalciumClinical Chemistry2
JGJPhotometric Method, MagnesiumClinical Chemistry1
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
KHSEnzymatic, Carbon-DioxideClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010670000
K040115000
K051108000
K934592000
K942782000
K950164000
K992140000
K993211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010670000PICCOLO CHLORIDE TEST SYSTEMAbaxis, Inc.2001-04-26CHJ
K040115000PICCOLO MAGNESIUM TEST SYSTEMAbaxis, Inc.2004-01-30JGJ
K051108000PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMAbaxis, Inc.2005-07-08CFJ
K934592000EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTORAbaxis, Inc.1994-04-06JJG
K942782000PICCOLO(TM)Abaxis, Inc.1995-03-13JJG
K950164000PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTORAbaxis, Inc.1995-04-13CHH
K992140000PICCOLO METLYTE 7 REAGENT DISCAbaxis, Inc.1999-08-26JLB
K993211000PICCOLO SODIUM TEST SYSTEMAbaxis, Inc.1999-10-25JGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EABA40000311PrimaryHIBCC0
EABA40000310Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Total lactate dehydrogenase (LDH) 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 lactate dehydrogenase (LDH) 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
+49 6155780210abaxis@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
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
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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