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Singapore HSA registration DE0505509

Thermo Scientific MAS® Omni•IMMUNE™

Singapore flagSingapore·CLASS C IVD·Microgenics Corporation·Registered February 26, 2021
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0505509
Registration Date
February 26, 2021
Change Notification Approval Date
July 28, 2023
Retention Due Date
February 25, 2026
Product description
MAS® Omni•IMMUNE™ is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include Omni•IMMUNE with patient serum specimens when assaying for any of the constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Product Owner
Name
Microgenics Corporation
Short Name
Microgenics Corporation
Address
46500 Kato Road,, Fremont, CA 94538, UNITED STATES
Registrant
Name
THERMO SCIENTIFIC MICROBIOLOGY PTE LTD
Address
33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Importer
Name
ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
Address
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model information
Model Name(s)
MAS® Omni•IMMUNE™ Level 1 MAS® Omni•IMMUNE™ Level 2 MAS® Omni•IMMUNE™ Level 3
Model Identifier(s)
OIM-101 OIM-202 OIM-303
About this record

Access comprehensive regulatory information for Thermo Scientific MAS® Omni•IMMUNE™ 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 DE0505509 and owned by Microgenics Corporation. The device was registered on February 26, 2021.

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