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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 1804155-1
Certificate EN ISO 13485: 2016 DOMIN_SX 1804155_1_2021

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

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

 

Werfen

A-49 (FIEE Complex), Okhla Industrial Area, Phase-2, New Delhi 110 020

Call +91-490-29-550

Email india@werfen.com