Manufacturer's By Device Philadelphia chromosome/BCR-ABL mRNA expression IVD kit nucleic acid technique (NAT)-Philadelphia chromosome/BCR-ABL mRNA expression IVD kit nucleic acid technique (NAT)

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
3B BlackBio Biotech India Limited7-C Industrial Area Govindpura

Bhopal Madhya Pradesh
462023

India
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/06/202120343
Abbott Molecular Inc.1350 E. Touhy Ave

Des Plaines IL
Illinois 60018

United States
Abbott Laboratories LimitedAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE

England United Kingdom
04/28/202213024
Advanced Molecular Diagnostics LTD.Biocity Nottingham Pennyfoot Street

Nottingham
Nottinghamshire NG1 1GF

United Kingdom





02/12/20209591
Advanced Molecular Diagnostics LTD.Biocity Nottingham Pennyfoot Street

Nottingham
Nottinghamshire NG1 1GF

United Kingdom





02/12/20209591
Asuragen Inc.2150 Woodward Street Suite 100

Austin
Texas 78744-1038

United States
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
11/05/202119678
Cepheid Inc904 Caribbean Drive

Sunnyvale
CA 94089

United States
Cepheid UK LtdOakley Court Kingsmead Business Park
Frederick Place
High Wycombe
HP11 1JU

England United Kingdom
12/23/202121497
DiaSorin Molecular LLC11331 Valley View St.

Cypress
California 90630

United States
DiaSorin S.p.A. UK BranchCentral Road

Dartford
DA1 5LR

United Kingdom
12/07/202120351
QIAGEN GmbHQIAGEn GmbH
Qiagen Str. 1 Hilden
Mettmann
Düsseldorf 40724

Germany
QIAGEN Manchester Ltd.QIAGEN Manchester Ltd. Citylabs 2.0
200 Hathersage Road
Manchester
M13 0BH

England United Kingdom
03/19/202112724