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Singapore HSA registration DE0502907

Bio-Rad BioPlex 2200 Anti-CCP Reagent Pack

Singapore flagSingapore·CLASS B IVD·Bio-Rad Laboratories, Inc.·Registered March 20, 2019
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0502907
Registration Date
March 20, 2019
Change Notification Approval Date
January 03, 2025
Retention Due Date
March 19, 2026
Product description
The BioPlex® 2200 Anti-CCP kit is a multiplex flow immunoassay intended for the semi-quantitative detection of IgG antibodies to Cyclic Citrullinated Peptide (CCP) in human serum and EDTA or heparinized plasma. Detection of CCP antibodies may be used as an aid in the diagnosis of rheumatoid arthritis and should be used in conjunction with other clinical information. The BioPlex 2200 Anti-CCP 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)
Assay Protocol File BioPlex 2200 Anti-CCP Calibrator Set BioPlex 2200 Anti-CCP Control Set BioPlex 2200 Anti-CCP Reagent Pack
Model Identifier(s)
12016865 6633200 6633230 6653250
About this record

Access comprehensive regulatory information for Bio-Rad BioPlex 2200 Anti-CCP Reagent Pack 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 DE0502907 and owned by Bio-Rad Laboratories, Inc.. The device was registered on March 20, 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