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 7-82: NCCLS C34-A2, Sweat Testing: Collection and Quantitative Analysis; Approved Guideline - Second Edition. (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: Chemistry, Toxicology, All IVDs Processes Affected: 510(K), PMA, IDE, PDP Type of Standard:  Vertical, National 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:   Arleen Pinkos   FDA/CDRH/OIVD   2098 GAITHER ROAD, HFZ-440   ROCKVILLE MD 20850   240/276-0490   Email: arleen.pinkos@fda.hhs.gov