Healgen Rapid Strep-A Antigen Test - 25/Box | CLIA Waived

For professional use only under a CLIA Certificate. Not for at-home or OTC use. Healgen Rapid Strep-A Antigen Test - 25 Tests/Box The Healgen Rapid Strep-A Antigen Test is a fast, reliable, and easy-to-use lateral flow immunoassay designed for the qualitative detection of Group A Streptococcal antigen directly from throat swab specimens. Ideal for clinics, hospitals, and point-of-care settings, this test delivers highly accurate results to aid in the diagnosis of Strep A infections without the need for specialized instrumentation. Key Features & Performance: Rapid Results: Get clear, visual results in approximately 5 minutes while the patient is still in the clinic. Clinical Accuracy: Exceptional reliability with 96.5% Sensitivity and 99.5% Specificity. Convenient Storage: Can be safely stored at room temperature and features a 24-month shelf life. Regulatory Status: Fully FDA 510(k) Cleared (K212623) and CLIA Waived for point-of-care use. User-Friendly Format: Simple test cassette design that includes external positive and negative controls for routine quality assurance. What's Included in the Box (25 Tests): 25 Test Cassettes 25 Sterile Throat Swabs 25 Extraction Tubes & Tube Holders Extraction Reagents A (Sodium Nitrite) & B (Acetic Acid) Positive & Negative External Controls Quick Reference Guide and Instructions for Use (IFU) Please Note: For professional and institutional use only by healthcare professionals in settings operating under a CLIA Certificate of Waiver, Compliance, or Accreditation. This product is not intended for at-home or OTC use.