{
  "url": "https://openlegislation.uk/eu-decision-2002-364/annex/division-3/division-10/division-1",
  "json_url": "https://openlegislation.uk/eu-decision-2002-364/annex/division-3/division-10/division-1.json",
  "legislation": "eudn/2002/364",
  "legislation_title": "Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (notified under document number C(2002) 1344) (Text with EEA relevance) (2002/364/EC)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2002-364",
  "path": "annex/division/3/division/10/division/1",
  "kind": "division",
  "number": "1",
  "heading": "Test reagents",
  "text": "Only by recommended techniques where reactivity against these antigens is claimed.\nNote: Polyclonal reagents must be tested against a wider panel of cells to confirm specificity and exclude presence of unwanted contaminating antibodies.\nBlood group reagents\nMinimum number of control cells to be tested\nPositive reactions\nNegative reactions\nA1\nA2B\nAx\nB\n0\nAnti-ABO1 (anti-A)\n2\n2\n2\n2\n2\nB\nA1B\nA1\n0\nAnti-ABO2 (anti-B)\n2\n2\n2\n2\nA1\nA2\nAx\nB\n0\nAnti-ABO3 (anti-A,B)\n2\n2\n2\n2\n4\nR1r\nR2r\nWeakD\nr’r\nr’r\nrr\nAnti-RH1 (anti-D)\n2\n2\n2\n1\n1\n1\nR1R2\nR1r\nr’r\nR2R2\nr’r\nrr\nAnti-RH2 (anti-C)\n2\n1\n1\n1\n1\n1\nR1R2\nR1r\nr’r\nR1R1\nAnti-RH4 (anti-c)\n1\n2\n1\n3\nR1R2\nR2r\nr’r\nR1R1\nr’r\nrr\nAnti-RH 3 (anti-E)\n2\n1\n1\n1\n1\n1\nR1R2\nR2r\nr’r\nR2R2\nAnti-RH5 (anti-e)\n2\n1\n1\n3\nKk\nkk\nAnti-KEL1 (anti-K)\n4\n3",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "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)."
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "Only by recommended techniques where reactivity against these antigens is claimed."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2002/364/annex/division/3/division/10/division/1",
    "retrieved_at": "2026-11-01T15:18:33.780237+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}