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.
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Manufacturer's By Device Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD kit enzyme immunoassay (EIA)-Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD kit enzyme immunoassay (EIA)
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Manufacturer
Address
Authorised Representative
Address
Date Registered
MHRA Reference Number
Diagnostic Automation / Cortez Diagnostics Inc.
21250 Califa St. Suite #102/116
Woodland Hills
CA 91367
United States
Invitech Ltd
Unit 4 Molesworth Business Estate Molesworth
Huntingdon
Cambs PE28 0QG
United Kingdom
11/05/2021
19800
Oy Reagena Ltd
Takojantie 18
Toivala
70900
Finland
Invitech Ltd
Unit 4 Molesworth Business Estate Molesworth
Huntingdon
Cambs PE28 0QG
United Kingdom
07/06/2021
15745