FDA Device Intelligence
Home › HARDY DIAGNOSTICS › N/A

N/A

HARDY DIAGNOSTICS · Model L75 · UDI-DI 00819398022514

JSH
10
510(k) clearances
173
Adverse events
2
Recalls
29
Facilities

Description

Dermatophyte Milk Agar, 6ml, 16x100mm tube, order by the package of 20 For the cultivation and differentiation of certain dermatophytes, especially Trichophyton rubrum, T. mentagrophytes, and Microsporum persicolor.

Recalls

DateFirmReason
2025-07-11Remel, IncThe products may contain surface and subsurface contamination of Listeria monocytogenes.
2017-03-24Remel IncConfirmed complaint of surface contamination of Listeria monocytogenes.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.