Singapore HSA registration DE0505100
Thermo Scientific MAS® Omni•CORE™
Singapore·CLASS C IVD·Microgenics Corporation·Registered November 03, 2020Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD