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Thermo Scientific MAS® DOA TOTAL - HSA Registration DE0504853

Access comprehensive regulatory information for Thermo Scientific MAS® DOA TOTAL 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 DE0504853 and owned by Microgenics Corporation. The device was registered on August 24, 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.

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CLASS B IVD
DE0504853
Thermo Scientific MAS® DOA TOTAL
HSA Registration Number: DE0504853
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Product Description

Thermo Scientific MAS® DOA TOTAL is intended for use as an assayed control for monitoring assay conditions in semi-quantitative and qualitative analysis of patient urine specimens for drugs and drug metabolites. These controls are human urine based and are composed of d-methamphetamine, secobarbital, nitrazepam, oxazepam, buprenorphine, benzoylecgonine, cotinine, ethyl glucoronide, ethanol, LSD, methadone, EDDP, methaqualone, morphone, oxycodone, phencyclidine, propoxyphene, nortriptyline, and L-∆-9-THC-COOH. DOA TOTAL provides an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0504853
Registration Date
August 24, 2020
Change Notification Approval Date
April 16, 2025
Retention Due Date
August 23, 2025
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® DOA TOTAL Level 1 MAS® DOA TOTAL Level 2 MAS® DOA TOTAL Level 3 MAS® DOA TOTAL Level 4 MAS® DOA TOTAL Level 5 MAS® DOA TOTAL Level 6 MAS® DOA TOTAL Level 1-6
Model Identifier(s)
DOAT-1 DOAT-2 DOAT-3 DOAT-4 DOAT-5 DOAT-6 DOAT-MP