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For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System

FDA product code NUK · Class N · Unknown

6
Registered devices
0
Adverse events
1
Recalls
0
510(k) clearances

Devices with this code

Trinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.

Recent recalls

DateFirmReason
2010-07-15BioCheck IncProducts were marketed without 510(k) for diagnostic use. Unapproved device.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.