HSA · registration DE0504853Thermo Scientific MAS® DOA TOTAL
- Registration number
- DE0504853
- Model name
- 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
- DOAT-1; DOAT-2; DOAT-3; DOAT-4; DOAT-5; DOAT-6; DOAT-MP
- Registration date
- August 24, 2020
- Source update date
- April 16, 2025
- Risk class
- Class B
- Product owner
- Microgenics Corporation
- Registrant / registration holder
- THERMO SCIENTIFIC MICROBIOLOGY PTE. LTD.
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 address
- 46500 Kato Road, Fremont, CA 94538, United States
- Registrant address
- 33 MARSILING IND ESTATE ROAD 3, #07-06, Singapore 739256
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.