Piccolo Xpress Military Deployment Kit

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…

Registry build 21.09.26

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.

3manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
1recall

Who Else Makes It

Concentrated in Zhejiang (2), Guangxi (1).

Chinese manufacturers registered for FDA product code JJG
Manufacturer City Province Registered as Device types
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Zhejiang Lidesen Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 100
Nanning Tecbod Biological Technology Co., Ltd. Nanning Guangxi Contract manufacturer 51

Record

Regulatory record for Piccolo Xpress Military Deployment Kit
Listed by Abaxis, Inc., United States
FDA product code JJG
Device type Analyzer, Chemistry, Centrifugal, For Clinical Use
Device class Class 1
Regulation 21 CFR 862.2140
Establishment Manufacturer
510(k) K934592
Record published 2017-06-30
Record revised 2025-07-30 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries serial number
Storage Handling environment temperature 15 to 32 °C; Handling environment temperature 59 to 90 °F; Handling environment humidity 8 to 80 % RH
Sizes Height 32.5 cm; width 14.9 cm; depth 21 cm; weight 5.3 kg

Catalogue Numbers

Catalogue numbers for Piccolo Xpress Military Deployment Kit
Catalogue number Size Status
1100-1511 Height 32.5 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Piccolo Xpress Abaxis, Inc. 1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K942782 1995-03-13
K934592 1994-04-06

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Piccolo Xpress Military Deployment Kit
Recalled by Identified by Initiated FDA class Root cause Reason Quantity Closed
Abaxis, Inc. 510(k) number 2019-12-11 Class II Software design Incorrect reference ranges of analytes. 15 2022-07-22

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer