Immucor's mission has always been about finding the right match. With the same focus #SpecializedDiagnostics, Werfen and Immucor are the right match. The Immucor team is excited to join Werfen and contribute to #PoweringPatientCare.

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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 3333620-1051
Certificate EN ISO 13485: 2016 DOMIN_SX 1804155_1_2021

Immucor GTI Diagnostics, Inc.
Waukesha, WI

MDSAP Certificate ISO 13485:2016 IMMGTI_MD_3333169-1011_EN
EC Certificate Annex II, List B Products Immucor GTI_EC HL 1804149-1
Certificate EN ISO 13485: 2016 IMMGTI_SX_1804149-1_EN

Immucor Medizinische Diagnostik GmbH
Dreieich, Germany

EC Certificate Full QA System IMMUC HL 1191616-1
EC Design Examination Certificate-Blood Grouping Kell IMMUC_IL 60139592
EC Design Examination Certificate Rhesus Blood Grouping IMMUC_IL 60139594
EC Design Examination Certificate ABO Blood Grouping IMMUC_IL 60139596
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 (immuClone (2) Anti-K IgM and Automated) IX 1191616-11
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 1191616-6
EU Certificate 2017/746 Annex IX (immuClone (1) Anti-E IgM and Galileo) IX 1191616-7
EU Certificate 2017/746 Annex IX (ImmuClone Anti-D fast IgM) IX 1191616-16
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 Quality Control K_IMMUCOR_IL 60139608
EC Design Examination Certificate Weak D Cells K_IMMUCOR_IL60139609
EC Design Examination Certificate Red Cells for Blood Grouping K_IMMUCOR_IL 60139610
EC Design Examination Certificate QC of Rhesus and Kell Blood Grouping Reagents K_IMMUCOR_IL 60139612
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 (Weak D Cells) IX 1804147-5

 

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Immucor

5 Isnor Drive, Dartmouth. NS, Canada B3B 1M1

Call 800.565.0653 or 902.468.3992

Fax 902.468.3599

Email [email protected]