Description

Rapid Fentanyl (FYL) Test Strip/Dipcard

Rapid Fentanyl (FYL) Test Strip is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut off of 1ng/ml.

Intended Use

Rx only- For Prescription Use Only.
For in vitro diagnostic use only.
For Forensic use only.

Fentanyl (FYL) Fentanyl is a potent, synthetic narcotic analgesic with a rapid onset and short duration of action. It is a strong agonist at the μ-opioid receptors. Historically it has been used to treat breakthrough pain and is commonly used in preprocedures as a pain reliever as well as an anesthetic in combination with a benzodiazepine. It is approximately 80 to 100 times more potent than morphine and roughly 15 to 20 times more potent than heroin.

The Cut-off Value and Approximate Detection Time

Drug(Identifier)	Cut-off level	Minimum detection time	Maximum detection time
Fentanyl (FYL)	1 ng/mL	8-24 hours	1-3 days

Description

Product Name	Fentanyl test strips (Urine)
Brand Name	CIBIO® or OEM
Format	Strip
Methodology	Colloidal Gold
Kit Contents	1. Test Strip
	2. Desiccant
	3. Instruction for use
Assay Type	Qualitative Detection
Specimen	Urine
Specification	Strip:  3.0 mm; 3.5 mm; 4.0 mm
Certificates	ISO 13485, FDA 510K
Accuracy	Over 99%
Storage Temperature	4-30 degree centigrade
Shelf Life	2 years ( 24 months )
Delivery time	15-30 days
OEM Services	Pouch, Box, Insert, private label
Cutoff level	1 ng/mL
Loading Port	Guangzhou or Shenzhen

Specimen Collection and Preparation

• Collect urine sample with a clean, dry container. Urine collected at any time of the day may be used.
• For best results, test specimens immediately following collection.
• Urine specimens may be refrigerated (2-8°C) and stored up to forty-eight hours. For longer storage, freeze the samples (-20°C or below).
• Bring frozen or refrigerated samples to room temperature before testing.

How To Perfrom The Test?

Test must be in room temperature (15°C to 30ºC)
1. Open the sealed pouch by tearing along the notch. Remove the test strip from the pouch.
2. Immerse the absorbent end into the urine sample for about 10 seconds. IMPORTANT：Do not allow the urine level to exceed
the MAX (marker line), otherwise the test will not perform correctly.
3. Lay the strip flat on a clean, dry, non-absorbent surface.
4. Read the results at 5 minutes. The drug test results remain stable for up to thirty minutes.

Reading The Results

Preliminary positive (+)
A rose-pink band is visible in each control region. If no color band appears in the appropriate test “T” region, a preliminary positive result is indicated for the corresponding drug of that specific test zone.

Negative (-)
If a rose-pink band is visible in each control region and theappropriate test “T” region, it indicates that the concentration of the
corresponding drug of that specific test zone is absent or below the detection limit of the test.

Invalid
If a color band is not visible in the control “C” region or a color band is only visible in the test “T” region, the test is invalid. Another test
should opened and run to re -evaluate the specimen. If test still provides an invalid result, please contact the distributor from whom
you purchased the product. When calling, be sure to provide the lot number for the test.

Certification