Histology & Cytology IVDs
Access comprehensive regulatory information for Histology & Cytology IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Abbott Rapid Diagnostics Pty Ltd, manufactured by Abbott Rapid Diagnostics Jena GmbH in Germany. The device registration started on July 17, 2020.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
Pima CD4 is an automated, image-based immune hematology test intended for the rapid in vitro quantitative measurement of CD3+/CD4+ T cells (T -helper cells) in capillary or venous whole blood. Pima CD4 determines the absolute count of CD3+/CD4+ cells and is intended to be used for the ongoing monitoring of absolute CD4 lymphocyte counts in patients with documented diagnosis of an immunodeficiency disease.