Singapore HSA registration DE0500498
Abaxis Piccolo Lipid Panel
Singapore·CLASS B IVD·Abaxis, Inc.·Registered March 03, 2017Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0500498
- Registration Date
- March 03, 2017
- Change Notification Approval Date
- April 16, 2025
- Retention Due Date
- March 02, 2026
Product description
The Piccolo Lipid Panel reagent disc, used with the Piccolo blood chemistry analyzer or the Piccolo Xpress Chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), and triglycerides (TRIG) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From these determinations low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer. Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders.
Product Owner
- Name
- Abaxis, Inc.
- Short Name
- Abaxis, Inc.
- Address
- 3240 Whipple Road, Union City, CA 94587, UNITED STATES
Registrant
- Address
- 2 KALLANG AVENUE, CT HUB, #05-04, SINGAPORE 339407
Importer
- Address
- 2 Kallang Avene, CT Hub, #05-04, SINGAPORE 339407
Model information
- Model Name(s)
- Piccolo Xpress chemistry analyzer Abaxis Chemistry Control Level 1 Abaxis Chemistry Control Level 2 PICCOLO Lipid Panel
- Model Identifier(s)
- 1100-0000E 1100-9131E 1100-9132E 400-0025
About this record
Access comprehensive regulatory information for Abaxis Piccolo Lipid Panel in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0500498 and owned by Abaxis, Inc.. The device was registered on March 03, 2017.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD