Piccolo Xpress Military Deployment Kit

Primary DI
EABA11001511
Brand
Piccolo Xpress Military Deployment Kit
Company
ABAXIS, INC.
Model
1100-1511
Catalog number
1100-1511
Device description
The Piccolo Xpress chemistry analyzer provides quantitative in-vitro determinations of clinical chemistry analytes in lithium-heparinized whole blood, heparinized plasma, or serum. This kit contains additional accessories for supporting US military requirements.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.
Published
2017-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJGAnalyzer, Chemistry, Centrifugal, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJGAnalyzer, Chemistry, Centrifugal, For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934592000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934592000EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTORAbaxis, Inc.1994-04-06JJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EABA11001511PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Centrifugal clinical chemistry analyserA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth21Centimeter
Height32.5Centimeter
Weight5.3Kilogram
Width14.9Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity8 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius32 Degrees Celsius
Handling Environment Temperature59 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (510) 675 6500abaxis@abaxis.com
1-800-822-2947Piccolo@abaxis.com
+496155780210abaxis@abaxis.de

Regulatory Flags#

DUNS number
555503770
Device count
1
Serial number
true

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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EABA40000031Piccolo Liver Panel Plus400-0003400-00032016-09-23
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EABA40000271Piccolo Renal Function Panel400-0027400-00272016-09-23
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EABA40000411Piccolo AmLyte 13400-0041400-00412016-09-23
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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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EABA110000001Piccolo XpressABAXIS, INC.JJG2016-09-23