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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Pointe Multi-Analyte Set D Urine DAU Negative Calibrator 1 x 15 mL The Pointe Multi-Analyte Set D Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of drugs ofabuse enzyme immunoassays for the detection of cocaine metabolite, d-methamphetamine, morphine, oxazepam, and oxycodone in human urine on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-MA1742-15
In Commercial Distribution

  • 00811727017611 ()
60-MA1742-15

  • Multiple drugs of abuse IVD, calibrator
Pointe Multi-Analyte Set C Urine DAU Level 2 Control 1 x 15 mL The Pointe Multi-Analyte Set C Controls are for use as controls in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of cocaine metabolite, d-methamphetamine, methadone, morphine, oxazepam, and secobarbital in human urine on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-MA1716-15
In Commercial Distribution

  • 00811727017604 ()
60-MA1716-15

  • Multiple drugs of abuse IVD, control
Pointe Multi-Analyte Set C Urine DAU Level 1 Control 1 x 15 mL The Pointe Multi-Analyte Set C Controls are for use as controls in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of cocaine metabolite, d-methamphetamine, methadone, morphine, oxazepam, and secobarbital in human urine on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-MA1714-15
In Commercial Distribution

  • 00811727017598 ()
60-MA1714-15

  • Multiple drugs of abuse IVD, control
Pointe Multi-Analyte Set C Urine DAU High Calibrator 1 x 15 mL The Pointe Multi-Analyte Set C Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of cocaine metabolite, d-methamphetamine, methadone, morphine, oxazepam, and secobarbital in human urine on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-MA1710-15
In Commercial Distribution

  • 00811727017581 ()
60-MA1710-15

  • Multiple drugs of abuse IVD, calibrator
Pointe Multi-Analyte Set C Urine DAU Intermediate Calibrator 1 x 15 mL The Pointe Multi-Analyte Set C Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of cocaine metabolite, d-methamphetamine, methadone, morphine, oxazepam, and secobarbital in human urine on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-MA1708-15
In Commercial Distribution

  • 00811727017574 ()
60-MA1708-15

  • Multiple drugs of abuse IVD, calibrator
Pointe Multi-Analyte Set C Urine DAU Cutoff Calibrator 1 x 15 mL The Pointe Multi-Analyte Set C Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of cocaine metabolite, d-methamphetamine, methadone, morphine, oxazepam, and secobarbital in human urine on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-MA1706-15
In Commercial Distribution

  • 00811727017567 ()
60-MA1706-15

  • Multiple drugs of abuse IVD, calibrator
Pointe Multi-Analyte Set C Urine DAU Low Calibrator 1 x 15 mL The Pointe Multi-Analyte Set C Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of cocaine metabolite, d-methamphetamine, methadone, morphine, oxazepam, and secobarbital in human urine on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-MA1704-15
In Commercial Distribution

  • 00811727017550 ()
60-MA1704-15

  • Multiple drugs of abuse IVD, calibrator
Pointe Universal Negative Calibrator 1 x 5 mL The Pointe Universal Negative Calibrator is for use as a negative calibrator in the qualitative and semi-quantitative calibration of Pointe Drugs of Abuse Reagent Sets on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-UN0002-5
In Commercial Distribution

  • 00811727016850 ()
60-UN0002-5

  • Multiple drugs of abuse IVD, calibrator
Pointe Hydrocodone 300 Level 2 Control (375 ng/mL) 1 x 5 mL The Pointe Hydrocodone 300 Controls are for use as assayed quality control materials to monitor the precision of the PointeHydrocodone 300 Reagent Set (Ref# 60-HY0780-100/60-HY0780-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-HY0796-5
In Commercial Distribution

  • 00811727016843 ()
60-HY0796-5

  • Multiple drugs of abuse IVD, control
Pointe Hydrocodone 300 Level 1 Control (225 ng/mL) 1 x 5 mL The Pointe Hydrocodone 300 Controls are for use as assayed quality control materials to monitor the precision of the PointeHydrocodone 300 Reagent Set (Ref# 60-HY0780-100/60-HY0780-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-HY0794-5
In Commercial Distribution

  • 00811727016836 ()
60-HY0794-5

  • Multiple drugs of abuse IVD, control
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