Piccolo BioChemistry Panel Plus

The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT),…

Registry build 21.09.26

The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), c-reactive protein (CRP), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total protein, blood urea nitrogen (BUN), and uric acid in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement.

2manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jilin (1), Shandong (1).

Chinese manufacturers registered for FDA product code CIT
Manufacturer City Province Registered as Device types
Dirui Industrial Co., Ltd. Changchun Jilin Contract manufacturer 84
Biobase Biodustry(Shandong)Co., Ltd. Jinan Shandong Manufacturer 70

Record

Regulatory record for Piccolo BioChemistry Panel Plus
Listed by Abaxis, Inc., United States
FDA product code CIT
Device type Nadh Oxidation/Nad Reduction, Ast/Sgot
Device class Class 2
Regulation 21 CFR 862.1100
Establishment Manufacturer
Record published 2016-09-23
Record revised 2025-08-18 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date, serial number
Storage Storage environment temperature 36 to 46 °F; Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Piccolo BioChemistry Panel Plus
Catalogue number Size Per pack Status
400-0035 10 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Biobase Biobase Biodustry(Shandong)Co., Ltd. 19
AST Randox Laboratories Limited 10
JAS Diagnostics Drew Scientific, Ltd. 7
Synermed® Infrared Laboratory Systems LLC 7
Pointe Scientific, Inc. Horiba Instruments Incorporated 5
AU Beckman Coulter, Inc. 4
Architect Abbott Ireland 4
Synchron Beckman Coulter, Inc. 4
ACE Alfa Wassermann 4
Architect Abbott Medical 3
Alinity Abbott Ireland 3
Architect Abbott Laboratories 3

Showing 12 of 62. All products under Nadh Oxidation/Nad Reduction, Ast/Sgot

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