Singapore HSA registration DE0508932
Cell Marque anti-NSE (MRQ-55) Mouse Monoclonal Primary Antibody
Singapore·CLASS B IVD·Cell Marque Corporation·Registered February 06, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Pathology
Registration information
- Registration Number
- DE0508932
- Registration Date
- February 06, 2024
- Change Notification Approval Date
- February 04, 2025
- Retention Due Date
- February 05, 2026
Product description
NSE (MRQ-55) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the NSE enzyme in formalin-fixed, paraffin-embedded tissue stained on VENTANA BenchMark IHC/ISH instruments. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This antibody is intended for in vitro diagnostic (IVD) use.
Product Owner
- Short Name
- Cell Marque Corporation
- Address
- 6600 Sierra College Blvd., Rocklin, CA 95677, UNITED STATES
Registrant
- Address
- 8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Importer
- Address
- 8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Model information
- Model Name(s)
- anti-NSE (MRQ-55) Mouse Monoclonal Primary Antibody
- Model Identifier(s)
- 760-4786 / 06648568001
About this record
Access comprehensive regulatory information for Cell Marque anti-NSE (MRQ-55) Mouse Monoclonal Primary Antibody 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 DE0508932 and owned by Cell Marque Corporation. The device was registered on February 06, 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 B IVD