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Thermo Scientific MAS® CardioImmune · XL - HSA Registration DE0505440

Access comprehensive regulatory information for Thermo Scientific MAS® CardioImmune · XL in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0505440 and owned by Microgenics Corporation. The device was registered on February 05, 2021.

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 C IVD
DE0505440
Thermo Scientific MAS® CardioImmune · XL
HSA Registration Number: DE0505440
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Product Description

MAS® CardioImmune · XL is intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0505440
Registration Date
February 05, 2021
Retention Due Date
February 04, 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
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model Information
Model Name(s)
MAS® CardioImmune® · XL Level 1 MAS® CardioImmune® · XL Level 2 MAS® CardioImmune® · XL Level 3 MAS® CardioImmune® · XL Level 1-3 MAS® CardioImmune® · XL Level L
Model Identifier(s)
CAI-XL1 CAI-XL2 CAI-XL3 CAI-XL4 CAI-XLL