Health Professionals
Accreditations
foodSCAN
foodSCAN Accreditation
YORKTEST Quality System Accreditation
Certification to ISO9001:2000
Certification to ISO13485:2003
Certification to ISO13485:2003 CMDCS (Canada)
YORKTEST foodSCAN Regulatory Compliance
Compliance with the European Medical Device Directive 93/42/EEC; for the manufacture of the sterile lancets
Compliance with the European In Vitro Diagnostic 98/79/EC; The blood collection device (for home use) and the reporting of results directly to the consumer in combination (but not including) the above Professional laboratory service, are covered by Annex III Section 6 of the IVD Directive. YORKTEST Laboratories fulfils the requirements of Annex III, Section 6 which include the Design Examination by the Notified Body (UL International).
YORKTEST Quality System Accreditation
Certification to ISO9001:2000
Certification to ISO13485:2003
Certification to ISO13485:2003 CMDCS (Canada)
YORKTEST foodSCAN Regulatory Compliance
Compliance with the European Medical Device Directive 93/42/EEC; for the manufacture of the sterile lancets
Compliance with the European In Vitro Diagnostic 98/79/EC; The blood collection device (for home use) and the reporting of results directly to the consumer in combination (but not including) the above Professional laboratory service, are covered by Annex III Section 6 of the IVD Directive. YORKTEST Laboratories fulfils the requirements of Annex III, Section 6 which include the Design Examination by the Notified Body (UL International).
Homocysteine
The YORKTEST homocysteine test, used in combination with the PSD collection device, has
been validated showing excellent reproducibility. Externally supplied Quality
Controls are assessed with each batch of samples, and these have to meet expected
defined ranges before the results are released to the consumer.
Stability studies have shown that homocysteine collected onto the PSD is very stable. Even after storage at high temperature (37ºC) the homocysteine, because it has been separated from the red blood cells immediately using the PSD, remains stable. This immediate separation of the blood plasma from the red cells is critical as homocysteine in whole blood is unstable.
YORKTEST have attained the following Certification, after independent audit, which covers the homocysteine service provided:-
ISO9001:2000
ISO13485:2003
EEC Medical Devices Directive; Annex V for the provision of sterile lancets
European In Vitro Diagnostic Directive 98/79/EC:-
The system for blood collection and transport, and the reporting of homocysteine results directly to the consumer in combination with a Professional laboratory service, are covered by Annex III Section 6 of the IVD Directive. YORKTEST Laboratories fulfils the requirements of Annex III, Section 6 which includes the successful Design Examination by the Notified Body (UL International).
The YORKTEST homocysteine testing service using the ‘PSD’ blood collection kit to collect the sample has been available since 2002. Since this time many consumers have used the service; a recent survey of the YORKTEST homocysteine service showing a very positive response.
Stability studies have shown that homocysteine collected onto the PSD is very stable. Even after storage at high temperature (37ºC) the homocysteine, because it has been separated from the red blood cells immediately using the PSD, remains stable. This immediate separation of the blood plasma from the red cells is critical as homocysteine in whole blood is unstable.
YORKTEST have attained the following Certification, after independent audit, which covers the homocysteine service provided:-
ISO9001:2000
ISO13485:2003
EEC Medical Devices Directive; Annex V for the provision of sterile lancets
European In Vitro Diagnostic Directive 98/79/EC:-
The system for blood collection and transport, and the reporting of homocysteine results directly to the consumer in combination with a Professional laboratory service, are covered by Annex III Section 6 of the IVD Directive. YORKTEST Laboratories fulfils the requirements of Annex III, Section 6 which includes the successful Design Examination by the Notified Body (UL International).
The YORKTEST homocysteine testing service using the ‘PSD’ blood collection kit to collect the sample has been available since 2002. Since this time many consumers have used the service; a recent survey of the YORKTEST homocysteine service showing a very positive response.
MAST
The MAST testing service provided by YORKTEST is compliant with the European In Vitro Diagnostic Directive 98/79/EC;
The blood collection system, transport of the sample and the reporting of results
directly to the consumer in combination with the above Professional laboratory
service, are covered by Annex III Section 6 of the IVD Directive. YORKTEST Laboratories fulfils the requirements of Annex III, Section 6 which include
the Design Examination by the Notified Body (UL International).
Since November 2002, the Company has (successfully) been a member of the UK NEQAS (United Kingdom National External Quality Assessments Service for Immunology and Immunochemistry) scheme for measurement of food and inhalant specific IgE’s.
Since November 2002, the Company has (successfully) been a member of the UK NEQAS (United Kingdom National External Quality Assessments Service for Immunology and Immunochemistry) scheme for measurement of food and inhalant specific IgE’s.