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Piccolo Xpress Military Deployment Kit

FDA UDI

Class I (US FDA UDI)

by Abaxis, Inc.

Identity

Trade Name
Piccolo Xpress Military Deployment Kit FDA UDI
Generic Name
Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Device Name
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. FDA UDI
Model / Reference
1100-1511 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
1100-1511 FDA UDI
Primary DI / UDI-DI
EABA11001511 FDA UDI
510(k) Number
K934592 FDA UDI
FDA Product Code
JJG FDA UDI
GMDN Term
Multiple clinical chemistry analyser IVD, laboratory FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2140 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Height — 32.5 Centimeter FDA UDI
Width — 14.9 Centimeter FDA UDI
Depth — 21.0 Centimeter FDA UDI
Weight — 5.3 Kilogram FDA UDI

Category: Multiple clinical chemistry analyser IVD, laboratory

Piccolo Xpress Military Deployment Kit by Abaxis, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry analyser IVD, laboratory.

Cleared under the same submission

K934592 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abaxis, Inc.

Sources (1)

  • FDA UDI c917a221-5f1b-43a0-ab1b-3890b1ab7487 38 fields · synced Jun 8, 2026