Singapore HSA registration DE0506919
Abbott Diagnostics Scarborough NMP22™ BladderChek™ Test
Singapore·CLASS C IVD·Abbott Diagnostics Scarborough, Inc.·Registered May 31, 2022Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0506919
- Registration Date
- May 31, 2022
- Change Notification Approval Date
- December 29, 2023
- Retention Due Date
- May 30, 2025
Product description
The NMP22™ BladderChek™ Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA), which is an abundant component of the nuclear matrix proteins, in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer. This test is indicated for professional use as an aid in diagnosing and monitoring bladder cancer patients, in conjunction with standard diagnostic procedures
Product Owner
- Short Name
- Abbott Diagnostics Scarborough, Inc.
- Address
- 10 Southgate Road, Scarborough, Maine 04074, UNITED STATES
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- Address
- 10 RAEBURN PARK, #01-33, SINGAPORE 088702
Model information
- Model Name(s)
- NMP22™ BladderChek™ Test NMP22™ BladderChek ™ Control Kit
- Model Identifier(s)
- D1200 D1250
About this record
Access comprehensive regulatory information for Abbott Diagnostics Scarborough NMP22™ BladderChek™ Test 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 DE0506919 and owned by Abbott Diagnostics Scarborough, Inc.. The device was registered on May 31, 2022.
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