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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 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 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
Pointe Hydrocodone 100 Level 2 Control (125 ng/mL) 1 x 5 mL The Pointe Hydrocodone 100 Controls are for use as assayed quality control materials to monitor the precision 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-HY0776-5
In Commercial Distribution

  • 00811727016768 ()
60-HY0776-5

  • Multiple drugs of abuse IVD, control
Pointe Hydrocodone 100 Level 1 Control (75 ng/mL) 1 x 5 mL The Pointe Hydrocodone 100 Controls are for use as assayed quality control materials to monitor the precision 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-HY0774-5
In Commercial Distribution

  • 00811727016751 ()
60-HY0774-5

  • Multiple drugs of abuse IVD, control
Pointe Multi-Analyte E DAU Level 1 Control 1 x 15 mL The Pointe Multi-Analyte Set E Controls are for use as controls in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of secobarbital, norbuprenorphine, methadone, and phencyclidine in human urine on anumber of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-MA1794-15
In Commercial Distribution

  • 00811727017734 ()
60-MA1794-15

  • Multiple drugs of abuse IVD, control
Pointe Multi-Analyte Set D Urine DAU Level 1 Control 1 x 15 mL The Pointe Multi-Analyte Set D Controls are for use as controls in the qualitative and semi-quantitative calibration of drugs of abuseenzyme 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-MA1754-15
In Commercial Distribution

  • 00811727017666 ()
60-MA1754-15

  • Multiple drugs of abuse IVD, control
SYNCHRON Systems DAT Multi-Drug Low Urine Control
Beckman Coulter, Inc.
474976
In Commercial Distribution

  • 15099590223328 ()
474976

  • Multiple drugs of abuse IVD, control
SYNCHRON Systems DAT Multi-Drug High Urine Control
Beckman Coulter, Inc.
474979
In Commercial Distribution

  • 15099590223311 ()
474979

  • Multiple drugs of abuse IVD, control
No Description
Microgenics Corporation
1815440
In Commercial Distribution

  • 00884883004856 ()


  • Multiple drugs of abuse IVD, control
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