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ANTITOXIN Anti-Cellano for card method monoclonal, IgG - HSA Registration DE0510192

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.

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CLASS C IVD
DE0510192
ANTITOXIN Anti-Cellano for card method monoclonal, IgG
HSA Registration Number: DE0510192
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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.

Device 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 Owner
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