Pure Global

Biokit Quantia lgE Assay (LN 6K42, 6K50 and 6K56) - HSA Registration DE0009823

Access comprehensive regulatory information for Biokit Quantia lgE Assay (LN 6K42, 6K50 and 6K56) 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 DE0009823 and owned by Biokit S.A.. The device was registered on August 31, 2012.

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
DE0009823
Biokit Quantia lgE Assay (LN 6K42, 6K50 and 6K56)
HSA Registration Number: DE0009823
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The reagents Quantia IgE are intended for the quantitative determination of immunoglobulin E (IgE) in human serum or plasma using the Abbott AEROSET® and ARCHITECT cSystems™.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
HSA Product Code
HSAMDB00106
HS Code
38220090
Registration Information
Registration Number
DE0009823
Registration Date
August 31, 2012
Change Notification Approval Date
October 06, 2022
Retention Due Date
August 30, 2025
Product Owner
Short Name
Biokit S.A.
Address
Av. Can Montcau 7, 08186 Lliçà d'Amunt, Barcelona, SPAIN
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)
Quantia lgE Quantia lgE Quantia lgE Standard Quantia lgE Standard Quantia Ferritin/ Myoglobin/ lgE Control Quantia Ferritin/ Myoglobin/ lgE Control
Model Identifier(s)
6K42-01 6K42-02 6K50-01 6K50-03 6K56-01 6K56-02