FDA.reportPublic FDA data

Piccolo MetLac 12 Panel

Primary DI
EABA40000371
Brand
Piccolo MetLac 12 Panel
Company
ABAXIS, INC.
Model
400-0037
Catalog number
400-0037
Device description
The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location.
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
CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
CGAGlucose Oxidase, Glucose
CGXAlkaline Picrate, Colorimetry, Creatinine
CHJMercuric Thiocyanate, Colorimetry, Chloride
CJWBromcresol Purple Dye-Binding, Albumin
CJYAzo Dye, Calcium
JGJPhotometric Method, Magnesium
JGSElectrode, Ion Specific, Sodium
KHPAcid, Lactic, Enzymatic Method
KHSEnzymatic, Carbon-Dioxide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDNUrease, Photometric, Urea NitrogenClinical Chemistry2
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CEOPhosphomolybdate (Colorimetric), Inorganic PhosphorusClinical Chemistry1
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CGXAlkaline Picrate, Colorimetry, CreatinineClinical Chemistry2
CHJMercuric Thiocyanate, Colorimetry, ChlorideClinical Chemistry2
CJWBromcresol Purple Dye-Binding, AlbuminClinical Chemistry2
CJYAzo Dye, CalciumClinical Chemistry2
JGJPhotometric Method, MagnesiumClinical Chemistry1
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1
KHSEnzymatic, Carbon-DioxideClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010670000
K022312000
K040115000
K130113000
K934592000
K942782000
K950164000
K992140000
K993211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010670000PICCOLO CHLORIDE TEST SYSTEMAbaxis, Inc.2001-04-26CHJ
K022312000PICCOLO PHOSPHORUS TEST SYSTEMAbaxis, Inc.2002-09-05CEO
K040115000PICCOLO MAGNESIUM TEST SYSTEMAbaxis, Inc.2004-01-30JGJ
K130113000PICCOLO LACTATE TEST SYSTEMAbaxis, Inc.2013-03-11KHP
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
EABA40000371PrimaryHIBCC0
EABA40000370Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Lactate 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 qualitative and/or quantitative detection of lactate 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.com
+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
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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