OpenLegislation

Division Qualifications:F1

United Kingdom

Original text. Later amendments are not shown.

Clinical samples

  • 10 % of the test population

    • Neonatal specimens

  • > 2 % of the test population

    • ABO samples

  • > 40 % A, B positives

    • ‘weak D’

  • > 2 % of RH1 (D) positives

    • Annotations

    Textual amendments

    F1

    Substituted by Commission Decision of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2009) 9464) (Text with EEA relevance) (2009/886/EC).

    Notes on Division 3

    Textual amendments

    F2

    Substituted by Commission Implementing Decision (EU) 2019/1244 of 1 July 2019 amending Decision 2002/364/EC as regards requirements for HIV and HCV antigen and antibody combined tests and as regards requirements for nucleic acid amplification techniques with respect to reference materials and qualitative HIV assays (notified under document C(2019) 4632) (Text with EEA relevance).

    F3

    Words in Annex Table 1 substituted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 3(d)

    F4

    Inserted by Commission Decision of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2011) 9398) (Text with EEA relevance) (2011/869/EU).

    Editorial notes

    X1

    Substituted by Corrigendum to Commission Decision 2009/886/EC of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (Official Journal of the European Union L 318 of 4 December 2009).

    Footnotes

    f1

    European Pharmacopoeia guideline.

    f2

    Acceptance criteria no neutralisation for HBsAg confirmatory assay.

    f3

    The total number of seroconversion panels for combined Ag/Ab assays (from tables 1 and 5) need not be greater than 30.