Pure Global

Sekisui Diagnostics Sekure ACETAMINOPHEN L3K® Assay - HSA Registration DE0500365

Access comprehensive regulatory information for Sekisui Diagnostics Sekure ACETAMINOPHEN L3K® Assay 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 DE0500365 and owned by Sekisui Diagnostics P.E.I. Inc.. The device was registered on November 04, 2015.

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B IVD
DE0500365
Sekisui Diagnostics Sekure ACETAMINOPHEN L3K® Assay
HSA Registration Number: DE0500365
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

For the IN VITRO quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
HSA Product Code
HSAMDB00106
HS Code
38220090
Registration Information
Registration Number
DE0500365
Registration Date
November 04, 2015
Change Notification Approval Date
November 22, 2022
Retention Due Date
November 03, 2025
Product Owner
Short Name
Sekisui Diagnostics P.E.I. Inc.
Address
70 Watts Ave., Charlottetown, Prince Edward Island, Canada C1E 2B9, CANADA
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model Information
Model Name(s)
Acetaminophen Reagent Acetaminophen Calibrator
Model Identifier(s)
506-10 506-30