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#1021225685 | Mfg #1.002.101 | Clinical Laboratory

Reagent binx io® Molecular Diagnostic Chlamydia Trachomatis / Neisseria Gohorrhoeae (CT / NG) For use with io Instrument 50 Tests

ASSAY, CT/NG BINX HEALTH IO SNGL-USE CARTRIDGE (50/CS) D/S
Reagent binx io® Molecular Diagnostic Chlamydia Trachomatis / Neisseria Gohorrhoeae (CT / NG) For use with io Instrument 50 Tests

Single use cartridge (10 Tests per pack, 5 Packs per Case)

Product Specifications

MSFH #
1021225685
Manufacturer #
1.002.101
Brand
binx io®
Manufacturer
Binx Health
Country of Origin
Unknown
Application
Reagent
CLIA Classification
CLIA Waived
Container Type
Cartridge
For Use With
For use with io Instrument
Number of Tests
50 Tests
Sample Type
Urine / Vaginal Swab Specimen
Test Name
Chlamydia Trachomatis / Neisseria Gohorrhoeae (CT / NG)
Test Type
Molecular Diagnostic
Time to Results
30 Minute Results

Description

The binx health io CT/NG Assay, when tested using the binx health io Instrument, is a fully automated, rapid, qualitative test intended for use in point-of-care or clinical laboratory settings for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA by polymerase chain reaction

The binx health io CT/NG test, designed to be performed in the clinic or decentralized laboratory while the patient waits, can enable immediate treatment of positive patients, removing the need for presumptive treatment, improving compliance, and reducing loss to follow-up

First ever FDA 510(k), CLIA-Waived CT/NG molecular test for males and females, enabling same-visit diagnosis and treatment

Gives results comparable to a laboratory-based test for chlamydia and gonorrhea in about 30 minutes rather than days or weeks

The binx health io CT/NG Assay is intended for use with female vaginal swab specimens, collected either by a clinician or self-collected by a patient in a clinical setting, or male urine specimens, as an aid in the diagnosis of symptomatic or asymptomatic Chlamydia trachomatis and/or Neisseria gonorrhoeae infection

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