Pure Global

Abbott Clinical Chemistry Creatinine (Enzymatic) Assay (LN 8L24 and 6K30) - HSA Registration DE0007820

Access comprehensive regulatory information for Abbott Clinical Chemistry Creatinine (Enzymatic) Assay (LN 8L24 and 6K30) 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 DE0007820 and owned by Sentinel CH. SpA. The device was registered on November 02, 2011.

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
DE0007820
Abbott Clinical Chemistry Creatinine (Enzymatic) Assay (LN 8L24 and 6K30)
HSA Registration Number: DE0007820
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The MULTIGENT Creatinine (Enzymatic) assay is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems and the AEROSET System.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
HSA Product Code
HSAMDB00106
HS Code
38220090
Registration Information
Registration Number
DE0007820
Registration Date
November 02, 2011
Change Notification Approval Date
October 06, 2022
Retention Due Date
December 31, 2025
Product Owner
Short Name
Sentinel CH. SpA
Address
Via Robert Koch 2, 20152 MILANO, ITALY
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)
Clin Chem Cal Clin Chem Control 1 Clin Chem Control 2 Creatinine (Enzymatic) Creatinine (Enzymatic)
Model Identifier(s)
6K30-10 6K30-20 6K30-21 8L24-31 8L24-41