HSA · registration DE0510637Siemens Syva® Emit® II Plus Ecstasy Assay
SingaporeClinical toxicologyClass BSiemens Healthcare Diagnostics Inc.
Official record identity
- Registration number
- DE0510637
- Model name
- Emit Calibrator/Control Level 0; Emit II Plus 6-AM/Ecstacy Calibrator/Control Level 1; Emit II Plus 6-AM/Ecstacy Calibrator/Control Level 2; Emit II Plus 6-AM/Ecstacy Calibrator/Control Level 3; Emit II Plus 6-AM/Ecstacy Calibrator/Control Level 4; Emit II Plus Ecstasy Assay; Emit II Plus Ecstasy Assay
- Model identifier
- 9A509UL; 9R529UL; 9R549UL; 9R569UL; 9R589UL; 9X029UL; 9X129UL
- Registration date
- April 25, 2025
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Siemens Healthcare Diagnostics Inc.
- Registrant / registration holder
- SIEMENS HEALTHCARE PTE. LTD.
Official description
The Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 500 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
Additional source fields
- Product owner address
- 500 GBC Drive, Mailstop 514,, PO Box 6101, Newark, DE 19714-6101,, United States
- Registrant address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, Singapore 348615
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.