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Nanoduct Neonatal Sweat Analysis System

ELITECHGROUP INC. · Model Nanoduct Sys 1030 · UDI-DI 03661540303418

KTB
1
510(k) clearances
40
Adverse events
0
Recalls
5
Facilities

Description

The Nanoduct Neonatal Sweat Analysis System is intended for laboratory use by qualified personnel to provide laboratory confirmation of a clinical diagnosis of cystic fibrosis.

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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.