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Singapore HSA registration DE0504843

Thermo Scientific MAS® CSF

Singapore flagSingapore·CLASS B IVD·Microgenics Corporation·Registered August 19, 2020
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0504843
Registration Date
August 19, 2020
Change Notification Approval Date
March 08, 2025
Retention Due Date
August 18, 2025
Product description
MAS® CSF is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many cerebrospinal fluid determinations. Include MAS CSF control with patient cerebrospinal fluid 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.
Product Owner
Name
Microgenics Corporation
Short Name
Microgenics Corporation
Address
46500 Kato Road,, Fremont, CA 94538, UNITED STATES
Registrant
Name
THERMO SCIENTIFIC MICROBIOLOGY PTE LTD
Address
33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Importer
Name
ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
Address
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model information
Model Name(s)
MAS® CSF (Level 1, Level 2)
Model Identifier(s)
CSF-MP
About this record

Access comprehensive regulatory information for Thermo Scientific MAS® CSF 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 DE0504843 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD