HSA · registration DE0510215Bio-Rad Biotestcell-A1& B, A2, O
- Registration number
- DE0510215
- Model name
- Biotestcell-O; Biotestcell-A2; Biotestcell-A1 & B
- Model identifier
- 12012453; 12012454; 12012455
- Registration date
- January 07, 2025
- Risk class
- Class D
- Product owner
- Bio-Rad Medical Diagnostics GmbH
- Registrant / registration holder
- BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Biotestcell-A1 & B, A2 are Reagent Red Blood Cells intended to be used for the qualitative detection of human ABO antibodies in donor and patient (recipient) plasma/serum in the manual slide/tile and tube method. Biotestcell-O are Reagent Red Blood Cells intended to be used for the qualitative detection of human non-ABO agglutinins, including anti-H in donor and patient (recipient) plasma/serum within ABO reverse grouping in the manual slide/tile and tube method. Whole blood collected in EDTA, citrate or without anticoagulant may be used. For in vitro diagnostic use, by trained laboratory personnel.
- Product owner address
- Industriestr. 1,, 63303 Dreieich, Germany
- 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.