Identity
- Trade Name
- Piccolo Hepatic Function Panel FDA UDI
- Generic Name
- Total alkaline phosphatase (ALP) IVD, reagent FDA UDI
- Device Name
- The Piccolo® Hepatic Function Panel, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, direct bilirubin, total bilirubin, and total protein in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. FDA UDI
- Model / Reference
- 400-0026 FDA UDI
- Description
- The Piccolo® Hepatic Function Panel, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, direct bilirubin, total bilirubin, and total protein in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. FDA UDI
Identifiers
- Catalog Number
- 400-0026 FDA UDI
- Primary DI / UDI-DI
- EABA40000261 FDA UDI
- FDA Product Code
- CKF FDA UDICKA FDA UDICJW FDA UDICEK FDA UDICIG FDA UDICIT FDA UDI
- GMDN Term
- Total alkaline phosphatase (ALP) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1050 FDA UDI862.1030 FDA UDI862.1035 FDA UDI862.1635 FDA UDI862.1110 FDA UDI862.1100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Alanine aminotransferase (ALT) IVD, reagentTotal aspartate aminotransferase (AST) IVD, reagentTotal protein IVD, reagentAlbumin IVD, reagent
Piccolo Hepatic Function Panel by Abaxis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total alkaline phosphatase (ALP) IVD, reagent.
- Alkaline phosphatase liquid acc to IFCC — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- Alkaline Phosphatase acc to IFCC Gen2 — Roche Diagnostics Corp. · Class II
- Alinity — Abbott · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- Alkaline phosphatase liquid acc to IFCC — Roche Diagnostics Corp. · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · 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 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 — ABAXIS, INC.
- Piccolo Xpress Military Deployment Kit — ABAXIS, INC.
K942782 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 Kidney Check — 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.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abaxis, Inc.
Sources (1)
- FDA UDI 224bae6a-b5d9-404d-a315-5803b8658fff 37 fields · synced May 30, 2026