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Singapore HSA registration DE0503415

Bio-Rad BioPlex 2200 25-OH Vitamin D

Singapore flagSingapore·CLASS B IVD·Bio-Rad Laboratories, Inc.·Registered August 01, 2019
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0503415
Registration Date
August 01, 2019
Change Notification Approval Date
April 30, 2025
Retention Due Date
July 31, 2025
Product description
The BioPlex 2200 25-OH Vitamin D Kit is a multiplex flow competitive immunoassay intended for the quantitative determination of 25-hydroxyvitamin D in human serum. The BioPlex 2200 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency. The BioPlex 2200 25-OH Vitamin D kit is intended for use with the Bio-Rad BioPlex 2200 System.
Product Owner
Name
Bio-Rad Laboratories, Inc.
Short Name
Bio-Rad
Address
4000 Alfred Nobel Drive, Hercules, California 94547, UNITED STATES
Registrant
Name
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
Name
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model information
Model Name(s)
BioPlex 2200 25-OH Vitamin D Calibrator Set BioPlex 2200 25-OH Vitamin D Control Set BioPlex 2200 25-OH Vitamin D Reagent Pack Assay Protocol File
Model Identifier(s)
12006552 12006554 6653750 Assay Protocol File
About this record

Access comprehensive regulatory information for Bio-Rad BioPlex 2200 25-OH Vitamin D 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 DE0503415 and owned by Bio-Rad Laboratories, Inc.. The device was registered on August 01, 2019.

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