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Thermo Scientific MAS® Omni•CORE™ - HSA Registration DE0505100

Access comprehensive regulatory information for Thermo Scientific MAS® Omni•CORE™ 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 DE0505100 and owned by Microgenics Corporation. The device was registered on November 03, 2020.

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
DE0505100
Thermo Scientific MAS® Omni•CORE™
HSA Registration Number: DE0505100
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Product Description

Thermo Scientific MAS® Omni•CORE™ is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include Omni•CORE with patient serum specimens when assaying for any of the constituents.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0505100
Registration Date
November 03, 2020
Retention Due Date
November 02, 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
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model Information
Model Name(s)
MAS® Omni•CORE™ Level 1 MAS® Omni•CORE™ Level 2 MAS® Omni•CORE™ Level 3
Model Identifier(s)
OCR-101 OCR-202 OCR-303