HSA · registration DE0510192ANTITOXIN Anti-Cellano for card method monoclonal, IgG
- Registration number
- DE0510192
- Model name
- Anti-Cellano for card method monoclonal, human IgG Clone: P3A1180L67
- Model identifier
- 01.233-03
- Registration date
- December 31, 2024
- Risk class
- Class C
- Product owner
- ANTITOXIN GmbH
- Registrant / registration holder
- ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
For in vitro diagnostic use only. Monoclonal Anti-Cellano reagent is produced from cell culture supernatants of heterohybridoma-cell lines. The cells are secreting an antibody of IgG-type, which reacts specific with the corresponding blood group antigen. The antibodies are human protein. The reagent is used to in-vitro determine qualitative whether human red blood cells possess or lack the corresponding blood group antigen Cellano. The reagent is intended to be used by qualified and technical personnel only.
- Product owner address
- ANTITOXIN GmbH, Industriestr. 88, 69245 Bammental, Germany
- Registrant address
- 1 INTERNATIONAL BUSINESS PARK, #01-12, THE SYNERGY, Singapore 609917
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.