Syphilis Health Check™ Tests rapid antigen test The emergency use of this

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food

or authorization is revoked sooner

User must be aged 14 + to perform self test

unless the declaration is terminated or authorization is revoked sooner

Performance:

Syphilis Health Check™ Tests rapid antigen test The emergency use of this1 box contains these components: 20 test cassettes, individually packed in sealed pouches 20 disposable plastic fixed volume pipettes (for whole blood only) packed in one pvc re sealable bag 1 diluent dropper bottle saline buffer, detergent and sodium azide (NaN3, 0. 1%) (5ml) 1 IFU (instruction for use) leaflet 1 Quick Reference Guide 1 master case = 76 boxes 1 pallet = 24 master cases or 12 master cases Intended use statement: Syphilis Health Check