HSA · registration DE0503267Bio-Rad Amplichek II
- Registration number
- DE0503267
- Model name
- 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
- 12000201; 12000202; 12000203; 12000204; 12000575; 12000576; 12000577; 12000578
- Registration date
- June 21, 2019
- Risk class
- Class B
- Product owner
- Bio-Rad Laboratories Inc.
- Registrant / registration holder
- BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
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 address
- 9500 Jeronimo Road, Irvine, CA 92618, United States
- Registrant address
- 3A INTERNATIONAL BUSINESS PARK, #11-10/16, ICON@IBP, Singapore 609935
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.