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| Product | Model | Company | Device type |
|---|---|---|---|
| Product | Model | Company | Device type |
|---|---|---|---|
Pointe Cannabinoid (THC) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Cannabinoids (THC) Reagent Set is intended for the qualitative and semi-quantitative determination of cannabinoids in human urine using 11-nor-9-THC-9-COOH, (referred to hereafter as THC). The calibrator at the cutoff has a value of 25 ng/mL, 50 ng/mL, or 100 ng/mL dependent on the chosen parameters. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. These assays are for prescription use only.
| Product | Model | Company | Device type |
|---|---|---|---|
| Pointe Barbiturate Reagent SetHoriba Instruments IncorporatedBarbiturate IVD, kit, enzyme immunoassay (EIA) | 60-BA0280-1L | Horiba Instruments Incorporated | Barbiturate IVD, kit, enzyme immunoassay (EIA) |
| Pointe Methamphetamine Reagent SetHoriba Instruments IncorporatedMethamphetamine-specific IVD, kit, enzyme immunoassay (EIA) | 60-MP0700-1L | Horiba Instruments Incorporated | Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA) |
| Pointe Opiates 300 Reagent SetHoriba Instruments IncorporatedOpiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) | 60-OP0040-100 | Horiba Instruments Incorporated | Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) |
| Pointe Carisporodol Metabolite (SOMA) Reagent SetHoriba Instruments IncorporatedCarisoprodol IVD, kit, enzyme immunoassay (EIA) | 60-CM0740-100 | Horiba Instruments Incorporated | Carisoprodol IVD, kit, enzyme immunoassay (EIA) |