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Abbott Diagnostics Scarborough NMP22™ BladderChek™ Test - HSA Registration DE0506919

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.

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CLASS C IVD
DE0506919
Abbott Diagnostics Scarborough NMP22™ BladderChek™ Test
HSA Registration Number: DE0506919
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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

Device 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 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