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HSA · registration DE0505440

Thermo Scientific MAS® CardioImmune · XL

SingaporeCardiovascularClass CMicrogenics Corporation
Verified
Official record identity
Registration number
DE0505440
Model name
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
CAI-XL1; CAI-XL2; CAI-XL3; CAI-XL4; CAI-XLL
Registration date
February 05, 2021
Classification
Risk class
Class C
Official value: CLASS C
Published category
Cardiovascular
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Published parties
Product owner
Microgenics Corporation
Registrant / registration holder
THERMO SCIENTIFIC MICROBIOLOGY PTE. LTD.
Official 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.

Additional source fields
Product owner address
46500 Kato Road,, Fremont, CA 94538, United States
Registrant address
33 MARSILING IND ESTATE ROAD 3, #07-06, Singapore 739256
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.