For in vitro diagnostic use. Others BUP IVD BUP CPS_000053 Buprenorphine Enzyme Immunoassay 09 067 752 190 9 067 752 190 09067752190 9067752190 09067752190 BUP, 240T, cobas c pack green, PCh BUP 00850624008513 Reagents, kits 240 tests cobas c 303/503 true 08 362 955 190 8 362 955 190 08362955190 8362955190 08362955190 BUP, 200T, cobas c, PCh BUP 00850624008018 Reagents, kits 200 tests cobas c 501/502 true 0009067752190c503 BUP Buprenorphine Enzyme Immunoassay en 3 FF0000000611930E FF00000004CDAD0E 09067752190 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 Buprenorphine Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative and semi‑quantitative determination of norbuprenorphine (a buprenorphine metabolite) in human urine. The cutoff for both the qualitative and semi‑quantitative modes of the assay is 5 ng/mL or 10 ng/mL of norbuprenorphine. 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 0209067752190c503 BUP Buprenorphine Enzyme Immunoassay en 3 FF0000000611F30E FF00000004F4940E 09067752190 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 Buprenorphine Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative and semi‑quantitative determination of norbuprenorphine (a buprenorphine metabolite) in human urine. The cutoff for both the qualitative and semi‑quantitative modes of the assay is 5 ng/mL or 10 ng/mL of norbuprenorphine. 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 0008362955190c501 BUP Buprenorphine Enzyme Immunoassay en 3 FF00000004F1400E FF000000026C670E 08362955190 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 Buprenorphine Enzyme Immunoassay is intended for the qualitative and semi‑quantitative determination of norbuprenorphine (a buprenorphine metabolite) in human urine at a cutoff value of 5 ng/mL and 10 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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