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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 Hydrocodone 300 Calibrator (500 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-HY0788-5
In Commercial Distribution

  • 00811727016812 ()
60-HY0788-5

  • 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 (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
Pointe Hydrocodone 100 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Hydrocodone 100 Reagent Set is intended for the qualitative and semi-quantitative determination of hydrocodone in human urine at a cutoff value of 100 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-HY0760-100
In Commercial Distribution

  • 00811727016690 ()
60-HY0760-100

  • Multiple drugs of abuse IVD, reagent
5 mL/bottle. Concentration: negative (drug-free) saliva buffer.
LIN-ZHI INTERNATIONAL, INC.
S0001
In Commercial Distribution

  • B076S00010 ()
S0001

  • Multiple drugs of abuse IVD, calibrator
15 mL/bottle. Concentration of Multi-Analyte: 3000 ng/mL benzoylecgonine, 2000 ng/mL d-methamphetamine, 1000 ng/mL morphine, 1000 ng/mL oxazepam, and 800 ng/mL oxycodone.
LIN-ZHI INTERNATIONAL, INC.
0915
In Commercial Distribution

  • B07609150 ()
0915

  • Multiple drugs of abuse IVD, calibrator
15 mL/bottle. Concentration of Multi-Analyte: 1000 ng/mL benzoylecgonine, 1500 ng/mL d-methamphetamine, 600 ng/mL morphine, 500 ng/mL oxazepam, and 500 ng/mL oxycodone.
LIN-ZHI INTERNATIONAL, INC.
0914
In Commercial Distribution

  • B07609140 ()
0914

  • Multiple drugs of abuse IVD, calibrator
15 mL/bottle. Concentration of Multi-Analyte: 300 ng/mL benzoylecgonine, 1000 ng/mL d-methamphetamine, 300 ng/mL morphine, 200 ng/mL oxazepam, and 300 ng/mL oxycodone.
LIN-ZHI INTERNATIONAL, INC.
0913
In Commercial Distribution

  • B07609130 ()
0913

  • Multiple drugs of abuse IVD, calibrator
15 mL/bottle. Concentration of Multi-Analyte: 150 ng/mL benzoylecgonine, 500 ng/mL d-methamphetamine, 150 ng/mL morphine, 100 ng/mL oxazepam, and 100 ng/mL oxycodone.
LIN-ZHI INTERNATIONAL, INC.
0912
In Commercial Distribution

  • B07609120 ()
0912

  • Multiple drugs of abuse IVD, calibrator
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