Singapore HSA registration DE0503267
Bio-Rad Amplichek II
Singapore·CLASS B IVD·Bio-Rad Laboratories Inc.·Registered June 21, 2019Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0503267
- Registration Date
- June 21, 2019
- Retention Due Date
- June 20, 2025
Product description
Amplichek II is intended for use as an external assayed quality control material to monitor the performance of in vitro laboratory nuclei acid testing procedures for the qualitative detection of Methicillin Resistant Staphylococcus aureus, Methicillin Sensitive Staphylococcus aureus, Clostridium difficile and Vancomycin-resistant Enterococci performed on Cepheid GeneXpert Systems. This product is not intended to replace manufacturer controls provided with the device. This product is only for use with assays and instruments listed in the Representative Results Chart in this labeling.
Product Owner
- Short Name
- Bio-Rad Laboratories Inc.
- Address
- 9500 Jeronimo Road, Irvine, CA 92618, UNITED STATES
Registrant
- Address
- 3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
- Address
- 3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model information
- Model Name(s)
- Amplichek II Negative Amplichek II Level 1 Amplichek II Level 2 Amplichek II Level 3 Amplichek II Negative MiniPak Amplichek II Level 1 MiniPak Amplichek II Level 2 MiniPak Amplichek II Level 3 MiniPak
- Model Identifier(s)
- 12000201 12000202 12000203 12000204 12000575 12000576 12000577 12000578
About this record
Access comprehensive regulatory information for Bio-Rad Amplichek II 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 DE0503267 and owned by Bio-Rad Laboratories Inc.. The device was registered on June 21, 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