Device Description : Pointe 6-Acetylmorphine Calibrator (0 ng/mL) Negative 1 x 5 mL The Pointe 6-Acet Pointe 6-Acetylmorphine Calibrator (0 ng/mL) Negative 1 x 5 mL The Pointe 6-Acetylmorphine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe 6-Acetylmorphine Reagent Set (Ref# 60-AC0580-100/60-AC0580-1L) on a number of automated clinical chemistry analyzers.
Device Class : 2
Duns Number: 045623154
Premarket Exempt : No
Prescription Use : Yes
Device Description : Pointe 6-Acetylmorphine Calibrator (5 ng/mL) Low 1 x 5 mL The Pointe 6-Acetylmor Pointe 6-Acetylmorphine Calibrator (5 ng/mL) Low 1 x 5 mL The Pointe 6-Acetylmorphine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe 6-Acetylmorphine Reagent Set (Ref# 60-AC0580-100/60-AC0580-1L) on a number of automated clinical chemistry analyzers.
Device Class : 2
Duns Number: 045623154
Premarket Exempt : No
Prescription Use : Yes
Device Description : Pointe 6-Acetylmorphine Calibrator (10 ng/mL) Cutoff 1 x 5 mL The Pointe 6-Acety Pointe 6-Acetylmorphine Calibrator (10 ng/mL) Cutoff 1 x 5 mL The Pointe 6-Acetylmorphine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe 6-Acetylmorphine Reagent Set (Ref# 60-AC0580-100/60-AC0580-1L) on a number of automated clinical chemistry analyzers.
Device Class : 2
Duns Number: 045623154
Premarket Exempt : No
Prescription Use : Yes
Device Description : Pointe 6-Acetylmorphine Calibrator (20 ng/mL) Intermediate 1 x 5 mL The Pointe 6 Pointe 6-Acetylmorphine Calibrator (20 ng/mL) Intermediate 1 x 5 mL The Pointe 6-Acetylmorphine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe 6-Acetylmorphine Reagent Set (Ref# 60-AC0580-100/60-AC0580-1L) on a number of automated clinical chemistry analyzers.
Device Class : 2
Duns Number: 045623154
Premarket Exempt : No
Prescription Use : Yes
Device Description : Pointe 6-Acetylmorphine Calibrator (40 ng/mL) High 1 x 5 mL The Pointe 6-Acetylm Pointe 6-Acetylmorphine Calibrator (40 ng/mL) High 1 x 5 mL The Pointe 6-Acetylmorphine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe 6-Acetylmorphine Reagent Set (Ref# 60-AC0580-100/60-AC0580-1L) on a number of automated clinical chemistry analyzers.
Device Class : 2
Duns Number: 045623154
Premarket Exempt : No
Prescription Use : Yes
Device Description : Pointe 6-Acetylmorphine Control (7.5 ng/mL) Level 1 1 x 5 mL The Pointe 6-Acetyl Pointe 6-Acetylmorphine Control (7.5 ng/mL) Level 1 1 x 5 mL The Pointe 6-Acetylmorphine Controls are for use as assayed quality control materials to monitor the precision of the Pointe 6-Acetylmorphine Reagent Set (Ref# 60-AC0580-100/60-AC0580-1L) on a number of automated clinical chemistry analyzers.
Device Class : 1
Duns Number: 045623154
Premarket Exempt : No
Prescription Use : Yes
Device Description : Pointe 6-Acetylmorphine Control (12.5 ng/mL) Level 2 1 x 5 mL The Pointe 6-Acety Pointe 6-Acetylmorphine Control (12.5 ng/mL) Level 2 1 x 5 mL The Pointe 6-Acetylmorphine Controls are for use as assayed quality control materials to monitor the precision of the Pointe 6-Acetylmorphine Reagent Set (Ref# 60-AC0580-100/60-AC0580-1L) on a number of automated clinical chemistry analyzers.
Device Class : 1
Duns Number: 045623154
Premarket Exempt : No
Prescription Use : Yes
Device Description : Pointe Methamphetamine Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Meth Pointe Methamphetamine Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Methamphetamine Reagent Set is intended for the qualitative and semi-quantitative determination of d-methamphetamine in human urine at a cutoff value of 500 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
Device Class : 2
Duns Number: 045623154
Premarket Exempt : No
Prescription Use : Yes
Device Description : Pointe Methamphetamine Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Meth Pointe Methamphetamine Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Methamphetamine Reagent Set is intended for the qualitative and semi-quantitative determination of d-methamphetamine in human urine at a cutoff value of 500 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
Device Class : 2
Duns Number: 045623154
Premarket Exempt : No
Prescription Use : Yes
Device Description : Pointe Methamphetamine Calibrator (250 ng/mL) Low 1 x 5 mL The Pointe Methamphet Pointe Methamphetamine Calibrator (250 ng/mL) Low 1 x 5 mL The Pointe Methamphetamine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Methamphetamine Reagent Set (Ref# 60-MP0700-100/60-MP0700-1L) on a number of automated clinical chemistry analyzers.
Device Class : 2
Duns Number: 045623154
Premarket Exempt : No
Prescription Use : Yes