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HSA · registration DE0505509

Thermo Scientific MAS® Omni•IMMUNE™

SingaporeImmunologyClass CMicrogenics Corporation
Verified
Official record identity
Registration number
DE0505509
Model name
MAS® Omni•IMMUNE™ Level 1; MAS® Omni•IMMUNE™ Level 2; MAS® Omni•IMMUNE™ Level 3
Model identifier
OIM-101; OIM-202; OIM-303
Registration date
February 26, 2021
Source update date
July 28, 2023
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

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.

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.