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Visby Medical Sexual Health PCR Test Kit – CT/NG/TV, 20 Tests, CLIA Waived

$2,48260
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Why you'll love it
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Three infections, one test. Detects chlamydia, gonorrhea and trichomoniasis DNA in a single run
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PCR in about 30 minutes. Visby states results can be expected in approximately 30 minutes
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Point-of-care ready. CLIA waived for use in settings holding a Certificate of Waiver
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Single-use device. Each fully integrated PCR device is disposable and runs on its own
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Built-in controls. Internal process control and electronic control check every run

Specifications

DetectsChlamydia (CT), Gonorrhea (NG), Trichomoniasis (TV)
MethodAutomated PCR, single-use device
SpecimenSelf-collected female vaginal swab, collected in a health care setting
Result timeApproximately 30 minutes
SettingPoint-of-care or clinical lab, CLIA waived
DispensingRx only, professional use
Storage36F to 86F (2C to 30C), 5% to 80% humidity
Operating temperature55F to 91F (13C to 33C)
Visby Medical
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Shipping & Returns

Returns are accepted within 30 days for unopened, unused items in their original packaging. Customers are responsible for return shipping.

Please note that some items, including select medical and diagnostic products, are final sale and not eligible for return.

View our full policy for complete details.

Description

Visby Medical Sexual Health PCR test for chlamydia, gonorrhea and trichomoniasis, CLIA waived

The Visby Medical Sexual Health Test is a single-use, fully integrated PCR device that detects DNA from chlamydia, gonorrhea and trichomoniasis in a vaginal swab specimen. This listing is for 20 test devices, with results expected in approximately 30 minutes.

It is designed for point-of-care and clinical laboratory settings that hold a CLIA Certificate of Waiver. The patient self-collects the swab in a health care setting, and a trained operator loads the sample and runs the test.

This is a prescription, professional-use test, and it is not for home use. It works only with the Visby Vaginal Specimen Collection Kit, and the Visby power adapter is needed to run each device. Review the manufacturer Instructions for Use before purchase.

What's in the box
20xVisby Medical Sexual Health Test device (single use)
Professional use, Rx only. The Visby Vaginal Specimen Collection Kit, Visby power adapter and fixed-volume pipettes are part of the test system; the collection kit and power adapter are separate accessories and are not confirmed as part of this listing.

Frequently asked questions
Is this a home test?

No. The Visby Instructions for Use state this test is not for use with self-collected specimens in a home setting. It is for point-of-care or clinical laboratory settings, with the patient collecting the swab in a health care setting.

Do I need a prescription?

The Instructions for Use state Rx only, and that US federal law restricts sale of this device to or on the order of a licensed practitioner.

What does it detect?

DNA from Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis, qualitatively, in self-collected female vaginal swab specimens.

What specimen can be used?

Only vaginal swabs collected with the Visby Medical Sexual Health Vaginal Specimen Collection Kit. Other specimen types and collection devices have not been evaluated.

What else is needed to run it?

The Visby power adapter, the Visby Vaginal Specimen Collection Kit, gloves, and external controls are listed in the IFU as required or available as accessories. A CLIA Certificate of Waiver is required to perform the test in a waived setting.

How long does a result take?

Approximately 30 minutes. Results may be read up to 2 hours after the run is completed.

How should the devices be stored?

Store the kit and devices between 36F and 86F (2C to 30C) and 5% to 80% humidity. Do not freeze. Allow a device to reach at least 55F (13C) before use.

Who is it intended for?

Performance has not been evaluated in women under 14 years of age. Results are to aid in diagnosis of symptomatic or asymptomatic infection and should be interpreted per the IFU.