DEVICE: Piccolo MetLac 12 Panel (EABA40000371)

Device Identifier (DI) Information

Piccolo MetLac 12 Panel
400-0037
In Commercial Distribution
400-0037
ABAXIS, INC.
EABA40000371
HIBCC

10
555503770 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Lactate IVD, reagent A 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.
Magnesium (Mg2+) IVD, reagent A 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 magnesium (Mg2+) in a clinical specimen.
Inorganic phosphate (PO43-) IVD, reagent A 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 inorganic phosphate (PO43-) [phosphorus] in a clinical specimen.
Chloride (Cl-) IVD, reagent A 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 chloride (Cl-) in a clinical specimen.
Sodium (Na+) IVD, control A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of sodium (Na+) in a clinical specimen.
Bicarbonate (HCO3-) IVD, reagent A 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 bicarbonate (HCO3-) in a clinical specimen.
Potassium (K+) IVD, reagent A 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 potassium (K+) in a clinical specimen.
Calcium (Ca2+) IVD, reagent A 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 calcium (Ca2+) in a clinical specimen.
Urea IVD, reagent A 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 urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.
Creatinine IVD, reagent A 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 creatinine in a clinical specimen.
Albumin IVD, reagent A 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 albumin in a clinical specimen.
Glucose IVD, reagent A 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 glucose in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
KHP Acid, Lactic, Enzymatic Method
JGJ Photometric Method, Magnesium
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
CHJ Mercuric Thiocyanate, Colorimetry, Chloride
JGS Electrode, Ion Specific, Sodium
KHS Enzymatic, Carbon-Dioxide
CEM Electrode, Ion Specific, Potassium
CJY Azo Dye, Calcium
CDN Urease, Photometric, Urea Nitrogen
CGX Alkaline Picrate, Colorimetry, Creatinine
CJW Bromcresol Purple Dye-Binding, Albumin
CGA Glucose Oxidase, Glucose
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K010670 000
K022312 000
K040115 000
K130113 000
K934592 000
K942782 000
K950164 000
K992140 000
K993211 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 36 and 46 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

6c2ced0e-e535-4db2-8ab2-0f9dd0bd3839
July 06, 2018
4
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: EABA40000370 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
1-800-822-2947
Piccolo@abaxis.com
+496155780210
abaxis@abaxis.com
+1 (510) 675 6500
abaxis@abaxis.com
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