Recognized Consensus Standards

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New Search Back To Search Results Recognition List Number: 009 Publication Date: 03/08/2004  Part B: SUPPLEMENTARY INFORMATION Recognition Number 7-97: NCCLS GP16-A2, Urinalysis and Collection, Transportation, and Preservation of Urine Specimens - Second Edition; Approved Guideline. (InVitro Diagnostics) Date of Standard: 2001.  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) DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD) Devices Affected: In Vitro Diagnostic Devices Processes Affected: IDE, 510(K), PMA, PDP, HDE 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:   Max Robinowitz, MD   FDA/CDRH/OIVD   2098 GAITHER ROAD, HFZ-440   ROCKVILLE, MD 20850   240/276-0493 ext: 136   Email: MYR@CDRH.FDA.GOV