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Thermo Scientific MAS® Omni•CARDIO™ - HSA Registration DE0509587

Access comprehensive regulatory information for Thermo Scientific MAS® Omni•CARDIO™ in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0509587 and owned by Microgenics Corporation. The device was registered on July 25, 2024.

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 IVD
DE0509587
Thermo Scientific MAS® Omni•CARDIO™
HSA Registration Number: DE0509587
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Product Description

Thermo Scientific MAS® Omni•CARDIO™ is intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions related to cardiac and associated critical marker determinations.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0509587
Registration Date
July 25, 2024
Retention Due Date
July 24, 2025
Product Owner
Short Name
Microgenics Corporation
Address
46500 Kato Road,, Fremont, CA 94538, UNITED STATES
Registrant
Address
33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Importer
Address
33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Model Information
Model Name(s)
MAS® Omni•CARDIO™ Liquid Assayed Integrated Cardiac Control
Model Identifier(s)
OCRD-UL