Singapore HSA registration DE0017121
VITROS Chemistry Products ALB Slides
Singapore·CLASS B IVD·Ortho-Clinical Diagnostic Inc·Registered May 11, 2015Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0017121
- Registration Date
- May 11, 2015
- Change Notification Approval Date
- July 07, 2020
- Retention Due Date
- May 10, 2026
Product description
VITROS ALB Slides quantitatively measure albumin (ALB) concentration in serum and plasma.
Product Owner
- Short Name
- Ortho-Clinical Diagnostic Inc
- Address
- 100 Indigo Creek Drive, Rochester, New York, 14626, New York, UNITED STATES
Registrant
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Importer
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model information
- Model Name(s)
- VITROS Chemistry Products Calibrator Kit 4 VITROS Chemistry Products ALB Slides (Albumin) VITROS Chemistry Products MicroSensor Fluids I & II Chemistry Products Performance Verifier I VITROS Chemistry Products ALB Slides (Albumin) VITROS Chemistry Products Performance Verifier II
- Model Identifier(s)
- 1204668 1988211 6801755 8067324 8196057 8231474
About this record
Access comprehensive regulatory information for VITROS Chemistry Products ALB Slides 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 DE0017121 and owned by Ortho-Clinical Diagnostic Inc. The device was registered on May 11, 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 DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD