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Specifications
Over-the-Counter or CLIA Waived use
Test type: Rapid Antigen
Run time: 1 minute
Collection type: urine
Limit of Detection: 1ng/mL
FDA 510(k)
Manufacturer: Phase Scientific
Storage & Expiration
Store at 4-30°C (39-86°F)
Do not freeze any contents of the kit.
Reagents and materials are stable until expiration date printed on outer packaging.
Test device must remain in the sealed pouch until use.
Box Components
Test strips (25)
Instructions for use (1)
Manuals & Documents
Intended Use
The INDICAID Fentanyl Drug Detection Test is a rapid, one-step immunoassay for the qualitative detection of fentanyl in human urine at the cutoff concentration of 1 ng/mL This device provide only preliminary drug test results. To obtain a quantitative result, or a confirmation of a presumptive positive result, a more specific alternative method must be used. GC/MS or LC/MS is the preferred confirmatory method. Professional judgment should be applied to drug test results, particularly when preliminary positive results are indicated. It is for in vitro diagnostics use only.