FDA Device Intelligence
Home › HARDY DIAGNOSTICS › N/A

N/A

HARDY DIAGNOSTICS · Model G101 · UDI-DI 00816576024834

JSH
10
510(k) clearances
181
Adverse events
2
Recalls
30
Facilities

Description

Corn Meal with Tween® 80, 15x60mm Plate, 13ml. Hardy Diagnostics Corn Meal Agar with Tween® 80 is recommended for use in the cultivation of fungi and for the inducement of chlamydospore formation by Candida albicans.

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.