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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 E DAU Low Calibrator 1 x 15 mL The Pointe Multi-Analyte Set E Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of secobarbital, norbuprenorphine, methadone, and phencyclidine in human urineon a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-MA1784-15
In Commercial Distribution

  • 00811727017697 ()
60-MA1784-15

  • Multiple drugs of abuse IVD, calibrator
Pointe Multi-Analyte Set D Urine DAU High 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-MA1750-15
In Commercial Distribution

  • 00811727017659 ()
60-MA1750-15

  • Multiple drugs of abuse IVD, calibrator
Pointe Multi-Analyte Set D Urine DAU Cutoff 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-MA1746-15
In Commercial Distribution

  • 00811727017635 ()
60-MA1746-15

  • Multiple drugs of abuse IVD, calibrator
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 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 Hydrocodone 300 Calibrator (150 ng/mL) 1 x 5 mL The Pointe Hydrocodone 300 Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Hydrocodone 300 Reagent Set (Ref# 60-HY0780-100/60-HY0780-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-HY0784-5
In Commercial Distribution

  • 00811727016799 ()
60-HY0784-5

  • Multiple drugs of abuse IVD, calibrator
Pointe Hydrocodone 100 Calibrator (300 ng/mL) 1 x 5 mL The Pointe Hydrocodone 100 Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Hydrocodone 100 Reagent Set (Ref# 60-HY0760-100/60-HY0760-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-HY0770-5
In Commercial Distribution

  • 00811727016744 ()
60-HY0770-5

  • Multiple drugs of abuse IVD, calibrator
Pointe Hydrocodone 100 Calibrator (150 ng/mL) 1 x 5 mL The Pointe Hydrocodone 100 Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Hydrocodone 100 Reagent Set (Ref# 60-HY0760-100/60-HY0760-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-HY0768-5
In Commercial Distribution

  • 00811727016737 ()
60-HY0768-5

  • Multiple drugs of abuse IVD, calibrator
Pointe Hydrocodone 100 Calibrator (50 ng/mL) 1 x 5 mL The Pointe Hydrocodone 100 Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Hydrocodone 100 Reagent Set (Ref# 60-HY0760-100/60-HY0760-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-HY0764-5
In Commercial Distribution

  • 00811727016713 ()
60-HY0764-5

  • Multiple drugs of abuse IVD, calibrator
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