Pure Global

ProciseDx ProciseDx Analyzer - HSA Registration DE0509723

Access comprehensive regulatory information for ProciseDx ProciseDx Analyzer 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 DE0509723 and owned by ProciseDx Inc.. The device was registered on September 03, 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.

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CLASS B IVD
DE0509723
ProciseDx ProciseDx Analyzer
HSA Registration Number: DE0509723
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Product Description

The ProciseDx instrument is intended for use with Procise assay cartridges manufactured by ProciseDx Inc. for the in vitro diagnosis and quantification of various targets or conditions in human patients. The platform should be used in accordance with user documentation and facility specific regulations. The ProciseDx System is designed to be used at the point-of-care, clinical laboratory, hospital laboratory, or near patient laboratory settings.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0509723
Registration Date
September 03, 2024
Change Notification Approval Date
September 11, 2024
Retention Due Date
September 02, 2025
Product Owner
Short Name
ProciseDx Inc.
Address
9449 Carroll Park DR, San Diego, CA, 92121 USA, UNITED STATES
Registrant
Address
400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Importer
Address
400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Model Information
Model Name(s)
ProciseDx Analyzer ProciseDx Calibration Cartridge Procise FCP Assay Method File (AMF)
Model Identifier(s)
4390 4759 Procise FCP Assay Method File (AMF)