DEVICE: Piccolo Xpress (EABA110000001)

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Device Identifier (DI) Information

Piccolo Xpress
1100-0000
1100-0000
ABAXIS, INC.
EABA110000001
HIBCC
1
The Piccolo Xpress chemistry analyzer provides quantitative in-vitro determinations of clinical chemistry analytes in lithium-heparinized whole blood, heparinized plasma, or serum. The Piccolo Xpress is a portable clinical chemistry system designed for accurate, on-site patient testing. It allows healthcare practitioners to perform routine multi-chemistry panels using 0.1cc of whole blood, serum or plasma. The system uses patented single-use reagent discs which contain up to 14 chemistry tests. Simply pipette the sample into the disc, insert the disc into the analyzer and results are printed or transferred to an LIS/EMR in about 12 minutes. No operator intervention is required. The Piccolo Xpress employs on-board continuous intelligent Quality Control (iQC®) to monitor the analyzer, reagent reactions and sample to ensure the highest quality and accuracy in results.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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

GMDN Preferred Term Name GMDN Definition
Centrifugal clinical chemistry analyser A mains electricity (AC-powered) automatic or semi-automated instrument that uses centrifugal force to transfer and mix liquids. It also monitors the resulting reactions in the centrifuge with, e.g., a photometer. A separate unit is required for dispensing samples and reagents.
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FDA Product Code

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Product Code Product Code Name
JJG Analyzer, Chemistry, Centrifugal, For Clinical Use
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Sterilization

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

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Storage and Handling
Handling Environment Humidity: between 8 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 59 and 90 Degrees Fahrenheit
Handling Environment Temperature: between 15 and 32 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Weight: 5.3 Kilogram
Depth: 21.0 Centimeter
Width: 14.9 Centimeter
Height: 32.5 Centimeter
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Device Status

In Commercial Distribution
September 23, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Yes
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Customer Contact

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