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Singapore HSA registration DE0504531

Abbott RealTime EBV

Singapore flagSingapore·CLASS C IVD·Abbott Molecular Inc·Registered June 01, 2020
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0504531
Registration Date
June 01, 2020
Retention Due Date
May 31, 2025
Product description
The Abbott RealTime EBV assay is an in vitro polymerase chain reaction (PCR) assay for the quantitation of Epstein-Barr Virus (EBV) DNA in human plasma or whole blood. This assay is not intended to be used as a screening test for EBV or as a diagnostic test to diagnose EBV infection.
Product Owner
Name
Abbott Molecular Inc
Short Name
Abbott Molecular Inc
Address
1300 E. Touhy Avenue, Des Plaines, IL, 60018, UNITED STATES
Registrant
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
Model Name(s)
Abbott RealTime EBV m2000 System ROW Combined Application CD-ROM Abbott RealTime EBV Calibrator Kit Abbott RealTime EBV Control Kit Abbott RealTime EBV Abbott RealTime EBV Amplification Reagent Kit Abbott m2000sp -E Series Abbott m2000sp Software Release 8.1 Abbott m2000rt Software Release 8.1 Abbott m2000rt
Model Identifier(s)
08N54-002 08N54-070 08N54-080 08N54-085 08N54-090 09K14-02 50-148440 50-148441 9K15-01
About this record

Access comprehensive regulatory information for Abbott RealTime EBV in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0504531 and owned by Abbott Molecular Inc. The device was registered on June 01, 2020.

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 C IVD