IMM_1338_Website_PageTitleBlock-Certifications

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) HX 1191616-1

Immucor, Inc.
Norcross, GA

MDSAP Certificate ISO 13485:2016 IMMUC_MDSAP MD1804147-1
EC Certificate Annex II, List A Products K_IMMUCOR_IL 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
EC Design-Examination Certificate Monoclonal Control K_IMMUCOR_IL 60139615
Certificate EN ISO 13485: 2016 IMMUCOR_ISO 13485 SX 1804147-1

 

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Immucor

3130 Gateway Drive, P.O. Box 5625, Norcross, GA 30091-5625

Call 855.IMMUCOR (855.466.8267) or 770.441.2051