Chrysalis Intelligence · Sponsors · Axis-Shield Diagnostics, Ltd.

Axis-Shield Diagnostics, Ltd.

Dundee, GB · 3 510(k) clearances

Total clearances
3
2024-07-31 → 2026-02-18
Last 12 months
1
Product codes
2
Most recent
2026-02-18
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NBC 2 2026-02-18
CDD Radioassay, Vitamin B12 Class II Clinical Chemistry 1 2024-07-31
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2026-02-18 K253539 Alere NT-proBNP for Alinity i NBC
2025-01-16 K241176 Alere NT-proBNP for Alinity i Reagent Kit NBC
2024-07-31 K233541 ARCHITECT Active-B12 (Holotranscobalamin) CDD Class II Clinical Chemistry