Singapore HSA registration DE0007820
Abbott Clinical Chemistry Creatinine (Enzymatic) Assay (LN 8L24 and 6K30)
Singapore·CLASS B IVD·Sentinel CH. SpA·Registered November 02, 2011Device 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 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.
Product Owner
- Name
- Sentinel CH. SpA
- 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
About this record
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 DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD