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 - Catachem Inc

Address:

353 Christian Street Suite 2

353 Christian Street Suite 2

Oxford

Connecticut 06478

United States

Authorised Representative/ UK Responsible Person
Name: NuuChem Diagnostics Limited
Address:

18 Killuney Road

Armagh

Armagh BT16 19HR

Northern Ireland United Kingdom

Code/Term Type

Ethylene glycol IVD reagent Ethylene glycol IVD reagent IVD General

Beta-hydroxybutyrate IVD reagent Beta-hydroxybutyrate IVD reagent IVD General

Fructosamine IVD reagent Fructosamine IVD reagent IVD General

Total bile acid IVD reagent Total bile acid IVD reagent IVD General

Methanol IVD reagent Methanol IVD reagent IVD General

Total haemoglobin (totHb) IVD kit spectrophotometry Total haemoglobin (totHb) IVD kit spectrophotometry IVD General

Haemoglobin detection IVD reagent Haemoglobin detection IVD reagent IVD General

Acetaminophen IVD reagent Acetaminophen IVD reagent IVD General

Salicylate IVD reagent Salicylate IVD reagent IVD General

Ethanol (ETOH) IVD reagent Ethanol (ETOH) IVD reagent IVD General

Free plasma haemoglobin IVD kit spectrophotometry Free plasma haemoglobin IVD kit spectrophotometry 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
Ethylene glycol IVD reagent	Ethylene glycol IVD reagent	IVD General
Beta-hydroxybutyrate IVD reagent	Beta-hydroxybutyrate IVD reagent	IVD General
Fructosamine IVD reagent	Fructosamine IVD reagent	IVD General
Total bile acid IVD reagent	Total bile acid IVD reagent	IVD General
Methanol IVD reagent	Methanol IVD reagent	IVD General
Total haemoglobin (totHb) IVD kit spectrophotometry	Total haemoglobin (totHb) IVD kit spectrophotometry	IVD General
Haemoglobin detection IVD reagent	Haemoglobin detection IVD reagent	IVD General
Acetaminophen IVD reagent	Acetaminophen IVD reagent	IVD General
Salicylate IVD reagent	Salicylate IVD reagent	IVD General
Ethanol (ETOH) IVD reagent	Ethanol (ETOH) IVD reagent	IVD General
Free plasma haemoglobin IVD kit spectrophotometry	Free plasma haemoglobin IVD kit spectrophotometry	IVD General