130814 Notified Body Certificate Chlamydia exp 14.8.2016

             

Ome ega Dia agnosttics Ltd d Hillfootss Business Village V Alva mannanshire Clackm Scotlan nd FK12 5DQ Q United Kingdom 

EC C Certific cate - Full F Qu uality Assuran A nce System Ap pprova al Certificate Annex IV, section 3 of Council Directive D 98/7 79/EC on In Vitro Diagno ostic Medica al Devices Scope of Certificate e: The Ma anufacture and a Distribu ution of In Vitro V Diagnos stic Reagen nt kits for detectiion of Chlam mydia SPP by b immunofluorescence e Device Classificatio on: Annex II List B Device Descriptionss: ydia Fluorottect Chlamy Model: OD019

File Number Certificcate No.

A17881 618 8.130814

Cyclle Start Date

14 August 2013

Efffective Date

14 August 2013

Expiry Date

14 August 2016

Authorrised by

  Brian Rodgers R Certificatio on Manager For and d on Behalf of UL U International (UK) Ltd We herreby declare that an exam mination of the t full qualitty assurance system has been carried d out per rep port 9447, followin ng the require ements of the e national legiislation to which the underrsigned is sub bject, transpos sing 4786039 Annex IIV (with the exemption e off sections 4 and a 6) of Cou uncil Directive e 98/79/EC on In Vitro Diagnostic Med dical Devices. We certiffy that the full quality assurance sy ystem conforms with the e relevant prrovisions of the entioned direc ctive and is su ubject to periodic surveillance as requirred by 98/79/ /EC, Annex IV V, Section 5. For aforeme Annex III, List A devic ces where the ey are covered d by this certifficate, an EC Design D Examination certific cate according g to 98/79/E EC, Annex IV, Section 4 is re equired.

Notiffied Body

0843  

OBL 00-NB--F0409 2.0