HSA · registration DE0507317Abbott Alinity i NSE
SingaporeImmunologyClass CAbbott GmbH
Official record identity
- Registration number
- DE0507317
- Model name
- NSE Assay Files; NSE Calibrators; NSE Controls; NSE Reagent Kit
- Model identifier
- 01R19-1A; 01R1901; 01R1910; 01R1922
- Registration date
- September 30, 2022
- Source update date
- November 19, 2025
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Abbott GmbH
- Registrant / registration holder
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Official description
The NSE assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of neuron-specific enolase (NSE) in human serum on the Alinity i system. The NSE assay is to be used as an aid in the monitoring of response to therapy and detection of recurrent disease, such as small cell lung carcinoma (SCLC) and neuroendocrine tumors.
Additional source fields
- Product owner address
- Max-Planck-Ring 2, 65205 Wiesbaden, Germany
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
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.