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Regulation/Guidelines

CDSCO Notifies To Update The Product Insert Of 4th Generation HIV In-Vitro Diagnostics Kit

NIB Noida is evaluating samples of in-vitro Diagnostics of 4th generation HIV kits for QC evaluation. While evaluating NIB, Noida noticed that many manufacturers of such Kits are not mentioning sensitivity for HIV P-24 antigen in the product insert. All the manufacturers or licensees are requested to update the product insert of these 4th generations HIV In-vitro diagnostic kits for inclusion of analytical sensitivity for HIV P-24 antigen so that there is no unnecessary delay in evaluation

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Regulation/Guidelines

New Classifications Of Non-Notified Medical Devices And IVDs In India By CDSCO

CDSCO has classified almost 1866 medical devices and 80 IVDs. There are 24 categories of medical devices and 3 Categories of Non- Notified In-Vitro Diagnostic Medical Device proposed by CDSCO.

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