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kidneyintelX.dkd Test

Renalytix Ai, Inc. · Model 1 · UDI-DI 00860009877924

QWZ Prescription
1
510(k) clearances
0
Adverse events
3
Recalls
1
Facilities

Description

Test Report for the kidneyintelX.dkd test.

Recalls

DateFirmReason
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.