Singapore HSA registration DE0501190
Abaxis Piccolo Comprehensive Metabolic Panel
Singapore·CLASS C·Abaxis, Inc.·Registered February 05, 2018Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0501190
- Registration Date
- February 05, 2018
- Change Notification Approval Date
- April 22, 2025
- Retention Due Date
- February 04, 2026
Product description
The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
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 Comprehensive Metabolic Panel
- Model Identifier(s)
- 1100-0000E 1100-9131E 1100-9132E 400-0028
About this record
Access comprehensive regulatory information for Abaxis Piccolo Comprehensive Metabolic Panel in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501190 and owned by Abaxis, Inc.. The device was registered on February 05, 2018.
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.
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