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HSA · registration DE0504842

Thermo Scientific MAS® Alcohol/Ammonia

SingaporeImmunologyClass BMicrogenics Corporation
Verified
Official record identity
Registration number
DE0504842
Model name
MAS® Alcohol/Ammonia (Level 1, Level 2)
Model identifier
AAC-MP
Registration date
August 19, 2020
Classification
Risk class
Class B
Official value: CLASS B
Published category
Immunology
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Published parties
Product owner
Microgenics Corporation
Registrant / registration holder
THERMO SCIENTIFIC MICROBIOLOGY PTE. LTD.
Official 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.

Additional source fields
Product owner address
46500 Kato Road, 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.