Singapore HSA registration DE0510192
ANTITOXIN Anti-Cellano for card method monoclonal, IgG
Singapore·CLASS C IVD·ANTITOXIN GmbH·Registered December 31, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0510192
- Registration Date
- December 31, 2024
- Retention Due Date
- December 30, 2025
Product description
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
- Name
- ANTITOXIN GmbH
- Short Name
- ANTITOXIN GmbH
- Address
- ANTITOXIN GmbH, Industriestr. 88, 69245 Bammental, GERMANY
Registrant
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Importer
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model information
- Model Name(s)
- Anti-Cellano for card method monoclonal, human IgG Clone: P3A1180L67
- Model Identifier(s)
- 01.233-03
About this record
Access comprehensive regulatory information for ANTITOXIN Anti-Cellano for card method monoclonal, IgG in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0510192 and owned by ANTITOXIN GmbH. The device was registered on December 31, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD