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Abaxis Piccolo Basic Metabolic Panel - HSA Registration DE0501191

Access comprehensive regulatory information for Abaxis Piccolo Basic 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 DE0501191 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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CLASS C
DE0501191
Abaxis Piccolo Basic Metabolic Panel
HSA Registration Number: DE0501191
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Product Description

The Piccoloยฎ Basic Metabolic Panel, used with the Piccolo blood chemistry analyzer or the PiccoloXpressยฎ chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, potassium, sodium, total carbon dioxide, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0501191
Registration Date
February 05, 2018
Change Notification Approval Date
April 22, 2025
Retention Due Date
February 04, 2026
Product Owner
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 Basic Metabolic Panel
Model Identifier(s)
1100-0000E 1100-9131E 1100-9132E 400-0024