Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - Diagnostics for the Real World Ltd

Address:

845 Embedded Way Suite 150

San Jose

CA 95138

United States

Authorised Representative/ UK Responsible Person
Name: MT Promedt Consulting Ltd
Address:

Beaver House 23-38 Hythe Bridge Street

Oxford

OX1 2EP

England United Kingdom

Code/Term Type

SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) IVD General

Isothermal nucleic acid amplification analyser IVD point-of-care Isothermal nucleic acid amplification analyser IVD point-of-care IVD General

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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Code/Term		Type
SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)	SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)	IVD General
Isothermal nucleic acid amplification analyser IVD point-of-care	Isothermal nucleic acid amplification analyser IVD point-of-care	IVD General