HSA · registration DE0510272Diamed DiaClon ABO/D (DVI+, DVI-) + Reverse Grouping
- Registration number
- DE0510272
- Model name
- DiaClon ABO/D (DVI+, DVI-) + Reverse Grouping
- Model identifier
- 001386
- Registration date
- January 22, 2025
- Source update date
- July 02, 2025
- Risk class
- Class D
- Product owner
- DiaMed GmbH
- Registrant / registration holder
- BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
The ID-Card ˝DiaClon ABO/D (DVI+, DVI-) + Reverse Grouping˝ is intended to be used for blood grouping, to determine the following antigens expressed on human donor and patient Red Blood Cells (RBCs): A (ABO1), B (ABO2) of the ABO Blood Group System (forward grouping) and D (RH1) of the Rh Blood Group System and to determine the presence of anti-A and anti-B in human serum or plasma (reverse grouping). The qualitative determination can be carried out manually or using instruments intended for the ID-System. For in vitro diagnostic use, by trained laboratory personnel.
- Product owner address
- Pra Rond 23, 1785 Cressier, FR, Switzerland, Switzerland
- 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.