Kit Rapid Strep A Ag Test (External Control included) Throat swab Cassette FDA 510(K) CLIA Waived by Healgen Scientific LLC ID GCSTR-501Ca

Rally #188-1-5151
Healgen Scientific #GCSTR-501Ca
Strep A Ag Test 25 Tests/Kit

Respiratory Test Kit, Rapid Antigen, Chromatographic Immunoassay, Strep A, Throat Swab, CLIA Waived.

Features

• Provides results in just 5 minutes, allowing for quick diagnosis of Group A Streptococcal infections.
• Utilizes a cassette-based format designed for easy, clean, and accurate application.
• Delivers high performance with 96.5% sensitivity and 99.5% specificity in clinical evaluations.
• Shelf-stable for up to 24 months for long-term storage and usability.
• External positive and negative controls included to help ensure the device is functioning properly.

The Healgen Rapid Strep A Antigen Test Kit (GCSTR‑501Ca) is a rapid, lateral flow immunoassay designed to qualitatively detect Group A Streptococcus (Streptococcus pyogenes) antigens from throat swab specimens. This test delivers clear results in just 5 minutes, using highly specific antibodies that react to Group A antigens. Each kit includes 25 self-contained cassette tests, with an internal control built into every test kit to help ensure proper performance. Intended to aid in the diagnosis of Strep A bacterial infections such as pharyngitis, this test offers a faster alternative to traditional culture methods. The kit is shelf-stable for up to 24 months, making it ideal for point-of-care use in clinical settings.

Important Notes:

• Restricted Product: Rx Only - Current Valid Medical License Required.
• Non-Returnable: Due to safety regulations, returns are not accepted for this item.
• This kit is for prescription, in vitro diagnostic use only.
• Swabs, tubes, and strips are for single use only. Do not re-use.
• Do Not Freeze: Freezing will damage the product and render it unusable.