The National Blood Service (England) Approach to Evaluation of Kits for Detecting Infectious Agents

References 

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3. Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices. Off J Eur Communities. 1998;L331:1–37
4. Medical Devices Agency Device Bulletin . Management of in vitro diagnostic medical devices, MDA DB2002(02). 2002;
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6. The HIV Testing Kits and Services Regulations Statutory Instrument. 1992;No. 460 ISBN: 011023460X
7. Delieu E, Perry KR, Parry JV. Access HCV Ab PLUS automated assay. Medical Devices Agency Evaluation Report 02027. 2002;(HMSO—ISBN 1 84182 517 4)
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