For in vitro diagnostic use. Others HYD IVD HYD CPS_000124 Hydrocodone Enzyme Immunoassay 09 067 736 190 9 067 736 190 09067736190 9067736190 09067736190 HYD, 240T, cobas c pack green, PCh HYD Reagents, kits 240 tests cobas c 503 true 08 239 819 190 8 239 819 190 08239819190 8239819190 08239819190 HYD, 200T, cobas c, PCh HYD 00850624008025 Reagents, kits 200 tests cobas c 501/502 true 0209067736190c503 HYD Hydrocodone Enzyme Immunoassay en 3 FF0000000770F20E FF0000000682880E 09067736190 9493 cobas c 303 8481 cobas c 503 Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative. Intended useThe Hydrocodone Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative and semi‑quantitative determination of hydrocodone in human urine. The cutoffs for the assay are 100 ng/mL and 300 ng/mL when calibrated against hydrocodone. The assay is designed for prescription use on the Roche cobas c analyzers.The semi‑quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas or liquid chromatography/mass spectrometry (GC‑MS or LC‑MS) or (2) permitting laboratories to establish quality control procedures.The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC‑MS or LC‑MS) are the preferred confirmatory methods.LREFUrine Testing for Drug of Abuse, National Institute on Drug Abuse (NIDA) Research Monograph 73 (1986).,LREFMandatory Guidelines for Federal Workplace Drug Testing Programs. Fed Regist 2017 Jan 23;82:7920-7970. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. en 0008239819190c501 HYD Hydrocodone Enzyme Immunoassay en 3 FF00000004F18D0E FF000000025B750E 08239819190 2324 cobas c 502 309 cobas c 501 Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative. Intended useThe Hydrocodone Enzyme Immunoassay is intended for the qualitative and semi‑quantitative determination of hydrocodone in human urine at a cutoff value of 100 ng/mL and 300 ng/mL. The assay is designed for prescription use with the Roche cobas c 501/502 automated clinical chemistry analyzers. The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC‑MS or LC‑MS) are the preferred confirmatory methods.LREFUrine Testing for Drug of Abuse, National Institute on Drug Abuse (NIDA) Research Monograph 73 (1986).,LREFMandatory Guidelines for Federal Workplace Drug Testing Program, National Institute on Drug Abuse, Federal Register 1988;53(69):11970. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. en

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