Manufacturer's By Device Acute myeloid leukaemia (AML) genetic mutation IVD kit nucleic acid technique (NAT)-Acute myeloid leukaemia (AML) genetic mutation 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
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 Italia S.p.A. UK BranchCentral Road

Dartford
DA1 5LR

England United Kingdom
12/07/202120351
Diatech Pharmacogenetics S.r.lVia Ignazio Silone 1b

JESI
Ancona 60035

Italy
BS Partnership Ltd41 Dan-Y-Coed Road Cyncoed
CARDIFF
CARDIFF
WALES CF23 6NB

Wales United Kingdom
02/13/202327799
Invivoscribe IncInvivoscribe Inc 10222 Barnes Canyon Road Bldg. 1

San Diego
California 92121-2711

United States
Gillian Pawlowsky Ltd272 Bath Street

Glasgow
G2 4JR

Scotland United Kingdom
02/01/202222546
Laboratory Corporation (LabCorp) of America Holdings531 South Spring Street

Burlington
North Carolina NC 27215

United States
European Device Solutions Ltd15 COANWOOD DRIVE Whitley Bay

WHITLEY BAY
TYNE AND WEAR NE25 9GB

England United Kingdom
04/13/202223486