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Thermo Scientific MAS® UrichemTRAK - HSA Registration DE0504854

Access comprehensive regulatory information for Thermo Scientific MAS® UrichemTRAK 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 DE0504854 and owned by Microgenics Corporation. The device was registered on August 24, 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
DE0504854
Thermo Scientific MAS® UrichemTRAK
HSA Registration Number: DE0504854
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Product Description

MAS® UrichemTRAK is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many urine determinations. Include UrichemTRAK with patient urine 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
Clinical chemistry
Registration Information
Registration Number
DE0504854
Registration Date
August 24, 2020
Retention Due Date
August 23, 2025
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
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model Information
Model Name(s)
MAS® UrichemTRAK Level 1 & Level 2 MAS® UrichemTRAK Level 1 MAS® UrichemTRAK Level 2
Model Identifier(s)
UR-MP UR11001 UR22002