FDA.reportPublic FDA data

Piccolo MetLyte Plus CRP

Primary DI
EABA40000341
Brand
Piccolo MetLyte Plus CRP
Company
ABAXIS, INC.
Model
400-0034
Catalog number
400-0034
Device description
The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of c-reactive protein (CRP), chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) 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
CEMElectrode, Ion Specific, Potassium
CGAGlucose Oxidase, Glucose
CGXAlkaline Picrate, Colorimetry, Creatinine
CHJMercuric Thiocyanate, Colorimetry, Chloride
DCNSystem, Test, C-Reactive Protein
JGSElectrode, Ion Specific, Sodium
JLBAtp And Creatine Kinase (Enzymatic), Creatine
KHSEnzymatic, Carbon-Dioxide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDNUrease, Photometric, Urea NitrogenClinical Chemistry2
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CGXAlkaline Picrate, Colorimetry, CreatinineClinical Chemistry2
CHJMercuric Thiocyanate, Colorimetry, ChlorideClinical Chemistry2
DCNSystem, Test, C-Reactive ProteinImmunology2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
JLBAtp And Creatine Kinase (Enzymatic), CreatineClinical Chemistry1
KHSEnzymatic, Carbon-DioxideClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010670000
K091052000
K934592000
K942782000
K992140000
K993211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010670000PICCOLO CHLORIDE TEST SYSTEMAbaxis, Inc.2001-04-26CHJ
K091052000PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEMAbaxis, Inc.2010-01-15DCN
K934592000EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTORAbaxis, Inc.1994-04-06JJG
K942782000PICCOLO(TM)Abaxis, Inc.1995-03-13JJG
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
EABA40000341PrimaryHIBCC0
EABA40000340Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
C-reactive protein (CRP) 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 C-reactive protein (CRP) 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
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
EABA40000311Piccolo Basic Metabolic Panel Plus400-0031400-00312016-09-23
EABA40000331Piccolo Kidney Check400-0033400-00332016-09-23
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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