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HSA · registration DE0509265

Thermo Scientific MAS® Bilirubin

SingaporeImmunologyClass BMicrogenics Corporation
Verified
Official record identity
Registration number
DE0509265
Model name
MAS® Bilirubin Liquid Assayed Bilirubin Control Level 1; MAS® Bilirubin Liquid Assayed Bilirubin Control Level 2; MAS® Bilirubin Liquid Assayed Bilirubin Control Level 3
Model identifier
BC101; BC102; BC103
Registration date
May 08, 2024
Classification
Risk class
Class B
Official value: CLASS B
Published category
Immunology
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Published parties
Product owner
Microgenics Corporation
Registrant / registration holder
THERMO SCIENTIFIC MICROBIOLOGY PTE. LTD.
Official description

MAS® Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Bilirubin with patient serum specimens when assaying for any of the listed 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.