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Certifications​​​​

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Certifications

BioArray Solutions Ltd.
Warren, NJ
EC Certificate Annex II, List A Products K_BIOARRAY_HL 60139758
EC Design Examination Certificate HEA BeadChip K_BIOARRAY_EC DESIGN EXAM_IL 60150261
MDSAP Certificate ISO 13485:2016 K_BIOARRAY_MD 1804154 3287530-130
Certificate EN ISO 13485: 2016 K_BIOARRAY_SX 60139759​


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 K_DOMINION_IL 60139701
MDSAP Certificate ISO 13485:2016 K_DOMINION_MDSAP MD 3333620-70
Certificate EN ISO 13485: 2016 K_DOMINION_ISO 13485 SX_1804155-1


Immucor GTI Diagnostics, Inc.
Waukesha, WI
MDSAP Certificate ISO 13485:2016 Immucor GTI_MDSAP-MD_3333169-70
EC Certificate Annex II, List B Products Immucor GTI_EC HL 1804149-1
Certificate EN ISO 13485: 2016 Immucor GTI_EN ISO 13485 SX 1804149-1


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 IMMUCOR_MDSAP_3330961-160
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 K_IMMUCOR_IL 60139613
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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