Kit Rapid Respiratory Syncytial Virus RSV Ag Test Cassette Nasa Swab FDA 510(K) CLIA Waived by Healgen Scientific LLC ID GCRSV-502b-US

188-1-5656
      
Stock Est. Shipping Date: 7th July 2025

Kit Rapid Respiratory Syncytial Virus RSV Ag Test Cassette Nasa Swab FDA 510(K) CLIA Waived
Sold by: KT OF 20

 Rx Item - Verified Medical Professional Only
 Reviews

Rally #188-1-5656
Healgen Scientific #GCRSV‑502b‑PBS (Alt: GCRSV-502b-US)
Rapid Check™ RSV Antigen Test (20 Test/KT)

Respiratory Test Kit, Rapid Antigen, Chromatographic Immunoassay, RSV, Nasal/Nasopharyngeal Swab or Aspirate, CLIA Waived.

Features
  • Delivers reliable RSV results in as little as 15 minutes
  • High-performance accuracy, with sensitivity and specificity both exceeding 99%
  • Compatible with nasal swab, nasopharyngeal swab, and nasal aspirate specimens
  • Each kit includes positive and negative quality controls for test verification
  • Compact, cassette-based format for convenient single-use testing
The Healgen Rapid Check™ RSV Antigen Test is a rapid diagnostic test designed to detect respiratory syncytial virus (RSV) antigens in symptomatic patients using nasal swab, nasopharyngeal swab, or nasal aspirate samples. Packaged in a convenient cassette format, the test delivers accurate and actionable results within 15 minutes, helping to identify RSV infections in both pediatric and elderly populations. Each kit includes positive and negative external controls to support reliable performance, and its compatibility with common transport media offers added flexibility in clinical settings. With a 24-month shelf life and room temperature storage, this test is ideal for respiratory diagnostics in point-of-care environments.

Features
  • Restricted Product: Rx Only - Current Valid Medical License Required.
  • This product is Non-Returnable. Please verify your ordering information before making a purchase.
  • For in vitro diagnostic use only.
  • Do Not Freeze: Freezing will damage the product and render it unusable.
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Rally #188-1-5656
Manufacturer #GCRSV‑502b‑PBS
Alternate Catalogue #GCRSV-502b-US
BrandRapid Check™
Product NameRSV Antigen Rapid Test
ManufacturerHealgen Scientific
Country of OriginUnknown
RegulatoryFDA 510(k) Cleared (K021789), CLIA Waived
ApplicationRapid qualitative detection of RSV antigen
IndicationFor use in symptomatic patients <6 years or ≥60 years of age
Test MethodChromatographic Immunoassay (lateral flow immunogold assay)
Sample TypeNasopharyngeal Swab, Nasal Swab
Number of Tests20 Tests/Kit
Test FormatSingle-use lateral-flow cassette
Reading TypeVisual interpretive ("two-band" readout)
Time to Results15 minutes
Sensitivity (PPA)99%
Specificity (NPA)99%
Accuracy98%
Shelf Life24 months from the date of manufacture
Storage Conditions2 °C – 30 °C (36 °F – 86 °F)
Transport MediumCompatible with PBS


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Configurations

Currently Not Available


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Package Contents
  • 20 Individually packaged test devices
  • 20 Sterile nasopharyngeal Swabs
  • 20 Extraction Tubes
  • 40 Disposable Pipettes
  • 1 x 2.0 mL R1 (Extraction Reagent Solution)
  • 1 x 1.0 mL PC (Positive Control Reagent)
  • 1 x 1.0 mL NC (Negative Control Reagent)
  • 1 Instructions for Use
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