The new list comprises 122 test categories — 46 general IVDs, 69 IVDs for specific diseases, and seven test categories for screening blood donations.
Using a fingerstick, the Mylan HIV Self Test can be completed at home and detects whether HIV antibodies are present in about 15 minutes.
The project, called Seq&Treat, will be implemented in Brazil, China, Georgia, India, and South Africa starting in October.
The study showed that the Zeesan test kit and qPCR instrument could be used for near-patient HPV typing of 94 samples in 2.5 hours.
The firm said it has multiple point-of-care tests available in Brazil and anticipates soon fulfilling an order for its dengue, chikungunya, and Zika tests.
The test for P. vivax-associated malaria was developed with support from FIND and will be distributed by Human Diagnostics Worldwide.
The approval advances Chembio’s commercial agreement with Bio-Manguinhos to develop and supply rapid diagnostic tests for Zika, dengue, and chikungunya.
Under the deal, Theradiag will have access to Immunodiagnostic's IDS-i10 automation system, and Immunodiagnostic will distribute Theradiag tests in 33 countries.
The agreement gives Inside Diagnósticos the right to sell Sienna’s hTERT test to pathology labs in Brazil for use as an adjunct to urine cytology.
The Vitros XT MicroSlide technology allows labs to run two tests that are commonly ordered together simultaneously from a single blood sample.