Binx IO CT/NG Assay rapid antigen The INDICAID™ COVID-19 Antigen Quality

The INDICAID™ COVID-19 Antigen Quality Controls are external liquid quality controls

20 disposable plastic fixed volume pipettes (for whole blood only) packed in one pvc re-sealable bag

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

Results are for the in vitro detection and differentiation ofSARS-CoV-2

Not FDA cleared for this use

Binx IO CT/NG Assay rapid antigen The INDICAID™ COVID-19 Antigen QualitySingle use Cartridge for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG)* Point of care (POC) molecular PCR testing for Chlamydia and Gonorrhea in both male and female patients* 30 minute time to result* Single visit test and treat* FDA cleared and CLIA waived* Fully automated* Integrates with EMR LIS* Clear detected not detected results* Accuracy: FEMALE Chlamydia: Sensitivity 96. 1%, Specificity 99. 1%,