Identity
- Trade Name
- Piccolo Xpress 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. 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
- 1100-0000 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. 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
- 1100-0000 FDA UDI
- Primary DI / UDI-DI
- EABA110000001 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
- Weight — 5.3 Kilogram FDA UDIDepth — 21.0 Centimeter FDA UDIWidth — 14.9 Centimeter FDA UDIHeight — 32.5 Centimeter FDA UDI
Category: Multiple clinical chemistry analyser IVD, laboratory
Piccolo Xpress by Abaxis, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Multiple clinical chemistry analyser IVD, laboratory.
- ZELLECHEM-PRO — STERILE SAFEQUIP & CHEMICALS LLP · Class I
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class I
- ABX PENTRA 400 ISE — Horiba Abx · Class I
- IDS-iSYS Cuvettes — IMMUNODIAGNOSTIC SYSTEMS FRANCE · Class I
- Alinity — Abbott Laboratories, Inc. · Class I
- Alinity — Abbott Laboratories, Inc. · Class I
- DYNEX DSX — DYNEX TECHNOLOGIES, INC. · Class I
- ABS800 Chemistry Analyzer — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
Cleared under the same submission
K934592 also covers:
- Piccolo AmLyte 13 — ABAXIS, INC.
- Piccolo Basic Metabolic Panel — ABAXIS, INC.
- Piccolo Basic Metabolic Panel Plus — ABAXIS, INC.
- Piccolo Comprehensive Metabolic Panel — ABAXIS, INC.
- Piccolo Hepatic Function Panel — ABAXIS, INC.
- Piccolo MetLac 12 Panel — ABAXIS, INC.
- Piccolo MetLyte 8 Panel — ABAXIS, INC.
- Piccolo MetLyte Plus CRP — ABAXIS, INC.
- Piccolo Renal Function Panel — ABAXIS, INC.
- Piccolo Xpress Military Deployment Kit — ABAXIS, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abaxis, Inc.
Sources (2)
- FDA UDI 3dd1b7ea-4ef6-4a2e-ba77-2a435ab5a32e 38 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026