Manufacturer's By Device BK virus (BKV) nucleic acid IVD kit nucleic acid technique (NAT)-BK virus (BKV) nucleic acid 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
Advanced Molecular Diagnostics LTD.Biocity Nottingham Pennyfoot Street

Nottingham
Nottinghamshire NG1 1GF

United Kingdom





02/12/20209591
altona Diagnostics GmbHaltona Diagnostics GmbH Mörkenstr. 12

22767 Hamburg
22767

Germany
altona diagnostics UK LtdNo 1 St Pauls Square

Liverpool
L3 9SJ

England United Kingdom
05/07/202114304
Anatolia Tan ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AHasanpasa Mah. Beydagi Sk
No: 1-9 H
Istanbul
Sultanbeyli 34920

Turkey
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
04/28/202114050
bioMérieux S.AbioMérieux S.A

Marcy L'Etoile (69280)
69280

France
bioMérieux UK LtdChineham Gate Crockford Lane

Basingstoke
Hampshire RG24 8NA

England United Kingdom
03/30/202113038
Clonit SrlVia Lombardia 6

Siziano
27010

Italy
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
12/10/202120449
Diagenode S.A.Rue du Bois Saint-Jean 3

Seraing
4102

Belgium
Hologic Ltd.Heron House 6 The Oaks Business Park Crewe Road Wythenshawe

Manchester
Lancashire M23 9HZ

England United Kingdom
06/14/202224848
Primerdesign LtdUnit 1 Watchmoor Point Watchmoor Road Camberley Surrey

Camberley
GU15 3AD

United Kingdom





08/04/20176351
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
Roche Molecular Systems Inc.Roche Molecular Systems Inc. 1080 US Highway 202 South

Branchburg
NJ 08876

United States
Roche Diagnostics LimitedRoche Diagnostics Limited Charles Avenue

Burgess Hill
West Sussex RH15 9RY

United Kingdom
04/26/202113715
Roche Molecular Systems Inc.Roche Molecular Systems Inc. 1080 US Highway 202 South

Branchburg
NJ 08876

United States
Roche Diagnostics LimitedRoche Diagnostics Limited Charles Avenue

Burgess Hill
West Sussex RH15 9RY

United Kingdom
04/26/202113715
SENTINEL CH. S.p.A.Via Robert Koch 2
Milano
MI
Lombardia 20152

Italy
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
08/10/202116678
TIB Molbiol Syntheselabor GmbhEresburgstraße 22–23

Berlin
D-12103

Germany
Roche Diagnostics LimitedRoche Diagnostics Limited Charles Avenue

Burgess Hill
West Sussex RH15 9RY

United Kingdom
02/11/202222855
Vela Operations Singapore Pte. Ltd.#05-07 The Kendall 50 Science Park Road

Singapore
117406

Singapore
MT Promedt Consulting LtdBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP

England United Kingdom
03/29/202223899
Viapath Analytics9 King's Head Yard

London
SE1 1HA

United Kingdom





10/23/20199170
Viapath Analytics9 King's Head Yard

London
SE1 1HA

United Kingdom





10/23/20199170