Recognized Consensus Standards

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New Search Back To Search Results Recognition List Number: 008 Publication Date: 03/11/2003  Part B: SUPPLEMENTARY INFORMATION Recognition Number 7-76: NCCLS M15-A, Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline. (InVitro Diagnostics) Date of Standard: 2000.  Address of Standards Organization:   NATIONAL COMMITTEE FOR CLINICAL LABORATORY STANDARDS (NCCLS)   940 WEST VALLEY ROAD   SUITE 1400   WAYNE, PA 19087   CDRH Office and Division Associated with Recognized Standards: OFFICE OF IN VITRO DIAGNOSTIC DEVICE EVALUATION AND SAFETY (OIVD) Devices Affected: IVDS Processes Affected: 510(K), PMA, IDE, PDP Extent of Recognition: Complete standard Relevant Guidance: There is no relevant guidance developed at this time. FDA Technical Contact:   Freddie Poole   FDA/CDRH/OIVD   10903 New Hampshire Avenue Building 66, Room 5520   Silver Spring MD 20993   301/796-5457   Email: freddie.poole@fda.hhs.gov