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HSA · registration DE0504854

Thermo Scientific MAS® UrichemTRAK

SingaporeClinical chemistryClass BMicrogenics Corporation
Verified
Official record identity
Registration number
DE0504854
Model name
MAS® UrichemTRAK Level 1 & Level 2; MAS® UrichemTRAK Level 1; MAS® UrichemTRAK Level 2
Model identifier
UR-MP; UR11001; UR22002
Registration date
August 24, 2020
Classification
Risk class
Class B
Official value: CLASS B
Published category
Clinical chemistry
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Published parties
Product owner
Microgenics Corporation
Registrant / registration holder
THERMO SCIENTIFIC MICROBIOLOGY PTE. LTD.
Official 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.

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.