Lin-Zhi International Inc

8 dispositifs dans la base de données

  • Modèle / numéro de série
    Catalog # 0808, lot number 1101137, Exp 1/28/2013
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including MA, FL, NC, NH, WA, and IN.
  • Description du dispositif
    Multi-Analyte Urine DAU Control (15 mL); || Level 2, For in-vitro diagnostic use only. || Lin-Zhi International, Inc. || 670 Almanor Ave. || Sunnyvale, CA 94085 || Multi-Analyte Urine Drug of Drug Abuse (DAU) Controls are for use as controls in the quantitative and semi-quantitative calibration of Amphetamines Enzyme, Opiate Enzyme, Phencyclidine Enzyme, Cocaine Metabolite Enzyme, Benzodiazepine Enzyme, Barbiturate Enzyme, Methadone Enzyme and Propoxyphene Enzyme on a number of automated clinical analyzers.
  • Modèle / numéro de série
    Catalog number 0803; Lot 1101136K3, exp 1/28/13
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AL, FL, GA, IN, NC, NH, and TX; and country of: Germany.
  • Description du dispositif
    Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) || For in vitro diagnostic use only. || Lin-Zhi International, Inc.. || 670 Almanor Ave. || Sunnyvale, CA 94085 || intended use: Drug abuse detection.
  • Modèle / numéro de série
    Catalog number 0007Cm; lot number 1211158R; Expiration May 14, 2014.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of SC, NC, LA, FL, TX,, AL and GA and Internationally to Germany.
  • Description du dispositif
    Cannabinoids DAU Calibrator Control Level 1 || (37.5 ng/mL) || This solution is prepared from non-sterile urine and should be handled as potentially infectious. || IVD; || The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free || matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,¿ 10% by GC/MS or LC/MS analysis. || Lin Zhi International inc. || Sunnyvale, CA 94085 || The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.
  • Modèle / numéro de série
    Catalog number 0008c; lot number 1211160R; Expiration May 14, 2014.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of SC, NC, LA, FL, TX,, AL and GA and Internationally to Germany.
  • Description du dispositif
    Cannabinoids DAU Calibrator Control Level 1 || (62.5 ng/mL) || This solution is prepared from non-sterile urine and should be handled as potentially infectious. || IVD; || The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free || matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,¿¿ 10% by GC/MS or LC/MS analysis. || Lin Zhi International inc. || Sunnyvale, CA 94085 || The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.
  • Modèle / numéro de série
    Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including CA.
  • Description du dispositif
    Single Analyte DAU Calibrator (5 mL) || Norbuprenorphine: Cutoff Calibrator; || IVD - for in vitro diagnostic use only; || Lin-Zhi International || Sunnyvale, CA || The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
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