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Thermo Scientific MAS® Bilirubin - HSA Registration DE0509265

Access comprehensive regulatory information for Thermo Scientific MAS® Bilirubin in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0509265 and owned by Microgenics Corporation. The device was registered on May 08, 2024.

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.

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CLASS B IVD
DE0509265
Thermo Scientific MAS® Bilirubin
HSA Registration Number: DE0509265
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Product 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.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0509265
Registration Date
May 08, 2024
Retention Due Date
May 07, 2026
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
33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Model Information
Model Name(s)
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(s)
BC101 BC102 BC103