Singapore HSA registration DE0504853
Thermo Scientific MAS® DOA TOTAL
Singapore·CLASS B IVD·Microgenics Corporation·Registered August 24, 2020Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD