Certifications
BioArray Solutions Ltd.
Warren, NJ
| EC Certificate Annex II, List A Products | K_BIOARRAY_HL 1804154-1 |
| EC Design Examination Certificate HEA BeadChip | K_BIOARRAY_EC DESIGN EXAM_IL 60150261 |
| MDSAP Certificate ISO 13485:2016 | K_BIOARRAY_MD 1804154-1 |
| Certificate EN ISO 13485: 2016 | K_BIOARRAY_SX 1804154-1 |
Dominion Biologicals Limited
Dartmouth, Canada
| EC Certificate Annex II, List A Products | K_DOMINION_EC CERT HL60149896 |
| EC Design Examination Certificate Rhesus Blood Grouping | K_DOMINION_IL 60139698 |
| EC Design Examination Certificate ABO and Rhesus Blood Grouping | K_DOMINION_IL 60139699 |
| EC Design Examination Certificate Blood Grouping | DOMIN_IL 1804155-1 |
| MDSAP Certificate ISO 13485:2016 | K_DOMINION_MDSAP MD 1804155-1 |
| Certificate EN ISO 13485: 2016 | DOMIN_SX 1804155_1_2021 |
| EU Certificate 2017/746 Annex IX Chapter I, Section 2 and 3 and Chapter III (Class C Products) | HX 1804155-1 |
Immucor GTI Diagnostics, Inc.
Waukesha, WI
| MDSAP Certificate | IMMGTI_MD_1804149-1-1_EN |
| EC Certificate Annex II, List B Products | Immucor GTI_EC HL 1804149-1 |
| Certificate EN ISO 13485: 2016 | IMMGTI_SX_1804149-1_EN |
| EU Certificate 2017/746 Annex IX (Class C) | HX_1804149-1 |
Immucor Medizinische Diagnostik GmbH
Dreieich, Germany
| EC Certificate Full QA System | IMMUC HL 1191616-1 |
| Certificate EN ISO 13485: 2016 | IMMUC_SX 1191616-1 |
| Certificate ISO 9001:2015 | IMMUC_01 100 1910002 |
| EU Certificate 2017/746 Annex IX (Class C and D) | HX 1191616-1 |
| EU Certificate 2017/746 Annex IX (Anti-K (Kell) quick) | IX 1191616-1 |
| EU Certificate 2017/746 Annex IX (immuClone Rh-Hr Control and Galileo) | IX 1191616-2 |
| EU Certificate 2017/746 Annex IX (immuClone (1) Anti-C IgM and Galileo) | IX 1191616-3 |
| EU Certificate 2017/746 Annex IX (immuClone (2) Anti-C IgM and Galileo) | IX 1191616-4 |
| EU Certificate 2017/746 Annex IX (immuClone (1) Anti-c IgM and Galileo) | IX 1191616-5 |
| EU Certificate 2017/746 Annex IX (immuClone (2) Anti-c IgM and Galileo) | IX 1191616-6 |
| EU Certificate 2017/746 Annex IX (immuClone (1) Anti-E IgM and Galileo) | IX 1191616-7 |
| EU Certificate 2017/746 Annex IX (immuClone (2) Anti-E IgM and Galileo) | IX 1191616-8 |
| EU Certificate 2017/746 Annex IX (immuClone (1) Anti-e IgM and Galileo) | IX 1191616-9 |
| EU Certificate 2017/746 Annex IX (immuClone (2) Anti-e IgM and Galileo) | IX 1191616-10 |
| EU Certificate 2017/746 Annex IX (immuClone (2) Anti-K IgM and Automated) | IX 1191616-11 |
| EU Certificate 2017/746 Annex IX (immuClone (1) Anti-K IgM and Galileo) | IX 1191616-12 |
| EU Certificate 2017/746 Annex IX (immuClone Anti-D duo IgM+IgG) | IX 1191616-13 |
| EU Certificate 2017/746 Annex IX (immuClone Anti-CDE IgM+ IgG and Galileo) | IX 1191616-14 |
| EU Certificate 2017/746 Annex IX (immuClone Anti-D rapid IgM and Galileo) | IX 1191616-15 |
| EU Certificate 2017/746 Annex IX (ImmuClone Anti-D fast IgM) | IX 1191616-16 |
| EU Certificate 2017/746 Annex IX (immuClone Anti-A,B IgM) | IX 1191616-17 |
| EU Certificate 2017/746 Annex IX (immuClone Anti-B IgM) | IX 1191616-18 |
| EU Certificate 2017/746 Annex IX (immuClone Anti-A IgM) | IX 1191616-19 |
Immucor, Inc.
Norcross, GA
| MDSAP Certificate ISO 13485:2016 | IMMUC_MDSAP MD1804147-1 |
| EC Certificate_Full Quality Assurance System_98/79/EC Annex IV (Annex II List A and B) | HL 1804147-1 |
| EC Design-Examination Certificate WBcorQC | IMMUC_NOR_IL 1804147-1 |
| Certificate EN ISO 13485: 2016 | IMMUCOR_ISO 13485 SX 1804147-1 |
| EU Certificate_Quality Management System_2017/746 Annex IX (Class C and D) | HX 1804147-1 |
| EU Certificate_Technical Documentation Assessment_2017/746 Annex IX (Monoclonal Control) | IX 1804147-1 |
| EU Certificate_Technical Documentation Assessment_2017/746 Annex IX (corQC EXTEND Complete; corQC EXTEND 1, 2 and 3; corQC EXTEND Standard) | IX 1804147-2 |
| EU Certificate_Technical Documentation Assessment_2017/746 Annex IX (Referencells -1, -2, -4) | IX 1804147-4 |
| EU Certificate_Technical Documentation Assessment_2017/746 Annex IX (Weak D Cells) | IX 1804147-5 |
| EU Certificate_Technical Documentation Assessment_2017/746 Annex IX (corQC Test System) | IX 1804147-7 |
