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Leica Novocastra Liquid Rabbit Monoclonal Antibody S-100 (EP32) - HSA Registration DE0505755

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.

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CLASS B IVD
DE0505755
Leica Novocastra Liquid Rabbit Monoclonal Antibody S-100 (EP32)
HSA Registration Number: DE0505755
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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 patientโ€™s clinical history and other diagnostic tests by a qualified pathologist.

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 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