CLIAwaived, Inc Rapid Strep A Tests
(25 Tests)
IN STOCK SHIPS IMMEDIATELY!
Customers placing orders for Strep Plus products will currently receive the HEALGEN BRAND BOX packaging. This will change towards the end of August 2025, when the new CLIA BRAND STREP PLUS BOX packaging will start shipping.
It's important to note that despite the change in packaging, the product inside – the Strep Plus test itself – remains exactly the same, as confirmed by the Healgen Rapid Strep A Antigen Test being FDA 510(k) cleared, CE-IVDD certified, and CLIA-waived. This means that the quality and performance of the test will not be affected by the packaging change.
The CLIAwaived,Inc. Rapid Strep A Test is a lateral-flow, membrane based immunoassay for the qualitative detection of Group A Streptococcal antigen from throat swab specimens. FDA 510(k) Cleared/CLIA Waived. (FOR PROFESSIONAL USE ONLY.) (FDA 510K#: K023270)