Toxismart FIA Reader for Fentanyl Test

CLIA Waived

INTENDED USE

Toxismart FIA Reader works with BioSieve Fentanyl FIA Pro Test Strips to provide healthcare professionals with a super fast and highly accurate readings for detection of Fentanyl in urine samples in just 5 mins. It is a handheld fluorescence reader for in vitro diagnostic use only.

 

PRODUCT INFORMATION

 Portable, only 0.36 lbs

 Simple operation

 Rechargeable Lithium Battery

 Handheld Bluetooth Reader

 Custom configurations available

 

Description
PRODUCT SPECIFICATIONS
Size 124.5 × 72.5 × 40 mm
Weight 5.76 oz (165 g)
Connectivity Bluetooth
Memory 999 results

 

KEY FEATURES

  • Ultra-Sensitive: 1ng/ml
  • Overall Accuracy: >99%
  • Results: Just in 5 minitues
  • Small Sample:  3 drops of urine
  • Portable: Use in Multiple Exam Rooms
  • Easy to Use: minimal training required
  • Handheld: light weight (5.76 oz)
  • Printable Results: via Bluetooth Printer
  • Reimbursable
  • Suggested ReimbursableCPT Code: 80306-QW

 

CLINICAL PERFORMANCE

Studies show that BioSieve Toxismart FIA Pro Syytem has a True Sensitivity of 1 ng/ml, while the competiro Brand “A” has a Sentivity between 3 – 5 ng/ml.

Sample Concentration Test Results
BioSieve Toxismart  Brand “A”     
0.5 ng/ml 10(-) / 0(+) 10(-) / 0(+)
1 ng/ml 0(-) / 10(+) 10(-) / 0(+)
1.5 ng/ml 0(-) / 10(+) 10(-) / 0(+)
2 ng/ml 0(-) / 10(+) 7(-) / 3(+)
3 ng/ml 0(-) / 10(+) 4(-) / 6(+)
4 ng/ml 0(-) / 10(+) 2(-) / 8(+)
5 ng/ml 0(-) / 10(+) 0(-) / 10(+)

 

Test Result (n=365) BioSieve Toxismart
Positive 0
Negative 365
Clinical Specificity 100%

 

Tutorial of Toxismart FIA Pro System Process

 

Shipping & Delivery