Axis-Shield Diagnostics, Ltd. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Alere NT-proBNP for Alinity i510(k)Feb 18, 2026Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Feb 18, 2026
Alere NT-proBNP for Alinity i Reagent Kit510(k)Jan 16, 2025Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jan 16, 2025
ARCHITECT Active-B12 (Holotranscobalamin)510(k)Jul 31, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jul 31, 2024