Rapid Check™
Rapid Check™ Respiratory Syncytial Virus RSV Antigen Test, CLIA Waived, 20/Box
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- SKU:
- GCRSV-502b-PBS
Description
Rapid Check™ Respiratory Syncytial Virus RSV Antigen Test, CLIA Waived, 20/Box
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ONLY AVAILABLE EXPIRATION DATE - 04/26
A rapid, single-use in vitro diagnostic device that provides a qualitative result to aid in the diagnosis of respiratory syncytial virus, a viral infection. Rapid Check™ Respiratory Syncytial Virus RSV Antigen Test, CLIA Waived, 20/Box is a professional diagnostic tool for the qualitative detection of RSV antigen from nasal swabs. For clinical point-of-care workflows, the Rapid Check Respiratory Syncytial Virus RSV Antigen Test supports rapid antigen detection from nasal swab specimens.
- Made in USA
- 510(k) Cleared and CLIA Waived for Prescription Use
- Detection of the fusion protein of respiratory syncytial virus
- Nasopharyngeal swab and nasal aspirate specimen
- Specimens collected from symptomatic patients aged less than 6 and over 60 years of age
- Sold by the Box of 20 Test Kits
Insurance Reimbursement CPT code 87807Q
RapidCheck RSV Antigen Test - Instructions For Use IFU
| RapidCheck™ RSV Antigen Test | ||
| |
Feature | Benefit |
| 1 | Rapid Detection & Patient Management | • RSV infection results in 15 minutes |
| 2 | Flexible Specimen Types | • Nasopharyngeal swab and/or nasal aspirates • Nasal aspirate is less invasive |
| 3 | Premier Performance* | • Positive Percent Agreement: 93.9% • Negative Percent Agreement: 97.7% *Nasopharyngeal swab and nasal aspirate performance. Refer to Instructions for Use for additional performance claims |
| 4 | CLIA Waived | • Demonstrates minimal training required • Capable of testing in point-of-care settings • Aids in Medicare/Medicaid reimbursement |
| 5 | Flexible Sample Transport | • Fresh, refrigerated, or frozen - immediate testing not required • Compatible with various viral transport medium • Remote collection of specimens if necessary |
| 6 | External Controls Included | • Color coded (Red/+, Blue/-) screw cap vials • Facilitate routine quality control inspection |
| 7 | 24 Month Shelf Life | • Shelf life that spans viral seasonality |
