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Thermo Scientific MAS® Alcohol/Ammonia - HSA Registration DE0504842

Access comprehensive regulatory information for Thermo Scientific MAS® Alcohol/Ammonia 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 DE0504842 and owned by Microgenics Corporation. The device was registered on August 19, 2020.

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
DE0504842
Thermo Scientific MAS® Alcohol/Ammonia
HSA Registration Number: DE0504842
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Product Description

Thermo Scientific MAS® Alcohol/Ammonia is intended for use in the clinical laboratory as a quantitative control for monitoring test procedures used to assay human serum and/or plasma specimens for alcohol and/or ammonia. Include Alcohol/Ammonia with patient serum or plasma specimens when assaying for alchohol and/or ammonia. Assay values are provided for 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
DE0504842
Registration Date
August 19, 2020
Retention Due Date
August 18, 2025
Product Owner
Short Name
Microgenics Corporation
Address
46500 Kato Road, UNITED STATES
Registrant
Address
33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Importer
Address
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model Information
Model Name(s)
MAS® Alcohol/Ammonia (Level 1, Level 2)
Model Identifier(s)
AAC-MP