Singapore HSA registration DE0505755
Leica Novocastra Liquid Rabbit Monoclonal Antibody S-100 (EP32)
Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0505755
- Registration Date
- May 05, 2021
- Retention Due Date
- May 04, 2026
Product description
For in vitro diagnostic use. NCL-L-S100-167 is intended for the qualitative identification by light microscopy of S-100B protein in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.
Product Owner
- Short Name
- Leica
- Address
- Balliol Business Park, Benton Lane, Newcastle upon Tyne, NE12 8EW, UNITED KINGDOM
Registrant
- Address
- 15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Importer
- Address
- 18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966 15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Model information
- Model Name(s)
- Novovastra Liquid Rabbit Monocloncal Antibody S-100 (EP32)
- Model Identifier(s)
- NCL-L-S100-167
About this record
Access comprehensive regulatory information for Leica Novocastra Liquid Rabbit Monoclonal Antibody S-100 (EP32) in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0505755 and owned by Leica Biosystems Newcastle Ltd. The device was registered on May 05, 2021.
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 B IVD