Recognized Consensus Standards

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New Search Back To Search Results Recognition List Number: 010 Publication Date: 06/01/2004  Part B: SUPPLEMENTARY INFORMATION Recognition Number 7-84: CEN 13640, Stability Testing of In Vitro Diagnostic Reagents. (InVitro Diagnostics) Date of Standard: 2002.  Address of Standards Organization:   EUROPEAN COMMITTEE FOR STANDARDIZATION (CEN)   CENTRAL SECRETARIAT   RUE DE STASSART 36   BRUSSELS,   BELGIUM CDRH Office and Division Associated with Recognized Standards: OFFICE OF IN VITRO DIAGNOSTIC DEVICE EVALUATION AND SAFETY (OIVD) Devices Affected: ANY DIAGNOSTIC REAGENTS Processes Affected: 510(K), PMA, IDE, PDP Extent of Recognition: Complete standard Related CFR Citations and Product Codes: Relevant Guidance: There is no relevant guidance developed at this time. FDA Technical Contact:   Josephine Bautista   FDA/CDRH/OIVD   2098 GAITHER ROAD, HFZ-440   ROCKVILLE MD 20850   240/276-0847   Email: josephine.bautista@fda.hhs.gov