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HSA · registration DE0509587

Thermo Scientific MAS® Omni•CARDIO™

SingaporeImmunologyClass CMicrogenics Corporation
Verified
Official record identity
Registration number
DE0509587
Model name
MAS® Omni•CARDIO™ Liquid Assayed Integrated Cardiac Control
Model identifier
OCRD-UL
Registration date
July 25, 2024
Classification
Risk class
Class C
Official value: CLASS C
Published category
Immunology
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Published parties
Product owner
Microgenics Corporation
Registrant / registration holder
THERMO SCIENTIFIC MICROBIOLOGY PTE. LTD.
Official 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.

Additional source fields
Product owner address
46500 Kato Road,, Fremont, CA 94538, United States
Registrant address
33 MARSILING IND ESTATE ROAD 3, #07-06, Singapore 739256
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.