HSA · registration DE0506093Abbott Alinity s Syphilis
- Registration number
- DE0506093
- Model name
- Alinity s Syphilis Assay File; Alinity s Syphilis Calibrator Kit; Alinity s Syphilis Assay Control Kit; Alinity s Syphilis Release Control Kit; Alinity s Syphilis Reagent Kit
- Model identifier
- 06P09-1B; 06P0902; 06P0910; 06P0912; 06P0955
- Registration date
- August 20, 2021
- Source update date
- August 28, 2024
- Risk class
- Class D
- Product owner
- Abbott GmbH
- Registrant / registration holder
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
The Alinity s Syphilis assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to Treponema pallidum (T pallidum, TP) in human serum and plasma, including specimens collected post-mortem (non-heart-beating) on the Alinity s System. The Alinity s Syphilis assay is intended to be used as an aid in the diagnosis of Syphilis infection and as a screening test to prevent transmission of T pallidum to recipients of blood, blood components, cells, tissue and organs.
- Product owner address
- Max-Planck-Ring 2, 65205 Wiesbaden, Germany
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
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.