TB Ag Skin test (Cy-Tb) for Mycobacterium tuberculosis infection diagnosis manufactured by Serum Institute of India Pvt. Ltd. (SIIPL) recently recommended for use by Expert Review Panel
13 August 2024
rdESAT-6 and rCFP-10 Injection (Cy-Tb skin test) manufactured by Serum Institute of India Pvt. Ltd. (SIIPL) has been recommended for use by the Expert Review Panel (ERP).
The recommendation is valid until August 9, 2025.
According to ERP assessment and considering the risk categorization of the product, pre-shipment Quality Control testing beyond what the applicant and SRAs are already performing is not considered mandatory. However, Principal Recipients procuring the product with The Global Fund funding, will need to request a Non-Objection Letter for monitoring purposes.