{"product_id":"healgen-rapid-strep-a-antigen-test","title":"Healgen Rapid Strep-A Antigen Test - 25\/Box | CLIA Waived","description":"\u003cp\u003e\u003cspan style=\"font-size: 10.5pt; font-family: 'Arial',sans-serif; mso-fareast-font-family: Aptos; mso-fareast-theme-font: minor-latin; color: #999999; background: white; mso-ligatures: standardcontextual; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;\"\u003eFor professional use only under a CLIA Certificate. Not for at-home or OTC use. \u003c\/span\u003e\u003c\/p\u003e\n\u003cp data-path-to-node=\"2\"\u003e\u003cb data-path-to-node=\"2\" data-index-in-node=\"0\"\u003eHealgen Rapid Strep-A Antigen Test - 25 Tests\/Box\u003c\/b\u003e\u003c\/p\u003e\n\u003cp data-path-to-node=\"3\"\u003eThe 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.\u003c\/p\u003e\n\u003cp data-path-to-node=\"4\"\u003e\u003cb data-path-to-node=\"4\" data-index-in-node=\"0\"\u003eKey Features \u0026amp; Performance:\u003c\/b\u003e\u003c\/p\u003e\n\u003cul data-path-to-node=\"5\"\u003e\n\u003cli\u003e\n\u003cp data-path-to-node=\"5,0,0\"\u003e\u003cb data-path-to-node=\"5,0,0\" data-index-in-node=\"0\"\u003eRapid Results:\u003c\/b\u003e Get clear, visual results in approximately \u003cb data-path-to-node=\"5,0,0\" data-index-in-node=\"58\"\u003e5 minutes\u003c\/b\u003e while the patient is still in the clinic.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp data-path-to-node=\"5,1,0\"\u003e\u003cb data-path-to-node=\"5,1,0\" data-index-in-node=\"0\"\u003eClinical Accuracy:\u003c\/b\u003e Exceptional reliability with \u003cb data-path-to-node=\"5,1,0\" data-index-in-node=\"48\"\u003e96.5% Sensitivity\u003c\/b\u003e and \u003cb data-path-to-node=\"5,1,0\" data-index-in-node=\"70\"\u003e99.5% Specificity\u003c\/b\u003e.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp data-path-to-node=\"5,2,0\"\u003e\u003cb data-path-to-node=\"5,2,0\" data-index-in-node=\"0\"\u003eConvenient Storage:\u003c\/b\u003e Can be safely stored at \u003cb data-path-to-node=\"5,2,0\" data-index-in-node=\"44\"\u003eroom temperature\u003c\/b\u003e and features a 24-month shelf life.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp data-path-to-node=\"5,3,0\"\u003e\u003cb data-path-to-node=\"5,3,0\" data-index-in-node=\"0\"\u003eRegulatory Status:\u003c\/b\u003e Fully \u003cb data-path-to-node=\"5,3,0\" data-index-in-node=\"25\"\u003eFDA 510(k) Cleared\u003c\/b\u003e (K212623) and \u003cb data-path-to-node=\"5,3,0\" data-index-in-node=\"58\"\u003eCLIA Waived\u003c\/b\u003e for point-of-care use.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp data-path-to-node=\"5,4,0\"\u003e\u003cb data-path-to-node=\"5,4,0\" data-index-in-node=\"0\"\u003eUser-Friendly Format:\u003c\/b\u003e Simple test cassette design that includes external positive and negative controls for routine quality assurance.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-path-to-node=\"6\"\u003e\u003cb data-path-to-node=\"6\" data-index-in-node=\"0\"\u003eWhat's Included in the Box (25 Tests):\u003c\/b\u003e\u003c\/p\u003e\n\u003cul data-path-to-node=\"7\"\u003e\n\u003cli\u003e\n\u003cp data-path-to-node=\"7,0,0\"\u003e25 Test Cassettes\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp data-path-to-node=\"7,1,0\"\u003e25 Sterile Throat Swabs\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp data-path-to-node=\"7,2,0\"\u003e25 Extraction Tubes \u0026amp; Tube Holders\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp data-path-to-node=\"7,3,0\"\u003eExtraction Reagents A (Sodium Nitrite) \u0026amp; B (Acetic Acid)\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp data-path-to-node=\"7,4,0\"\u003ePositive \u0026amp; Negative External Controls\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003cp data-path-to-node=\"7,5,0\"\u003eQuick Reference Guide and Instructions for Use (IFU)\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-path-to-node=\"8\"\u003e\u003ci data-path-to-node=\"8\" data-index-in-node=\"0\"\u003ePlease 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.\u003c\/i\u003e\u003c\/p\u003e","brand":"SMC Direct LLC","offers":[{"title":"Default Title","offer_id":67686344556653,"sku":null,"price":49.75,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0247\/3295\/8829\/files\/BoxG1-RapidStrepAAntigenTest.png?v=1791502646","url":"https:\/\/smcdirectonline.com\/products\/healgen-rapid-strep-a-antigen-test","provider":"SMC Direct LLC","version":"1.0","type":"link"}