Manufacturer's By Device Inherited thrombophilia IVD kit nucleic acid technique (NAT)-Inherited thrombophilia 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
GeneProof a.s.101/119 Dolní Heršpice
Vídeská Brno
Brno-msto
Jihomoravský kraj 619 00

Czechia
Pathway Diagnostics LtdEclipse House Curtis Road

Dorking
Surrey RH4 1EJ

United Kingdom
05/19/202224319
Hain Lifescience GmbHHardwiesenstr. 1
Nehren Württ
Landkreis Tübingen
Tübingen 72147

Germany
Bruker UK LimitedBanner Lane

Coventry
CV4 9GH

England United Kingdom
04/22/202212957
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
Seegene Inc.Taewon Bldg. 91 Ogeum-ro Songpa-gu

Seoul
05548

South Korea
MT Promedt Consulting LtdBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP

England United Kingdom
08/11/202116731