For in vitro diagnostic use. Others EDDP IVD EDDP CPS_000099 Methadone Metabolite Enzyme Immunoassay 08735581190 EDDP, 200, cobas c, PCh EDDP 00850624008179 Reagents, kits 200 tests cobas c 501/502 true 09067671190 EDDP, 200T, cobas c pack green, PCh EDDP 00850624008247 Reagents, kits 200 tests cobas c 303/503 true 0008735581190c501 EDDP Methadone Metabolite Enzyme Immunoassay en 3 FF00000004F1940E FF0000000332140E 08735581190 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 Methadone Metabolite Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of methadone metabolite (EDDP) in human urine. The cutoffs for both the qualitative and semi-quantitative modes of the assay are 100 ng/mL and 300 ng/mL of methadone metabolite. The assay is designed for prescription use with the Roche cobas c 501/502 automated clinical chemistry analyzers.The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for verification 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 0109067671190c503 EDDP Methadone Metabolite Enzyme Immunoassay en 3 FF0000000611940E FF00000004851C0E 09067671190 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 Methadone Metabolite Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of methadone metabolite (EDDP) in human urine. The cutoffs for both the qualitative and semi-quantitative modes of the assay are 100 ng/mL and 300 ng/mL of methadone metabolite. The assay is designed for prescription use with the Roche cobas c automated clinical chemistry analyzers.The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for verification 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 0209067671190c503 EDDP Methadone Metabolite Enzyme Immunoassay en 3 FF0000000612780E FF00000004F5920E 09067671190 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 Methadone Metabolite Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of methadone metabolite (EDDP) in human urine. The cutoffs for both the qualitative and semi-quantitative modes of the assay are 100 ng/mL and 300 ng/mL of methadone metabolite. The assay is designed for prescription use with the Roche cobas c automated clinical chemistry analyzers.The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for verification 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