FDA Device Intelligence
Home › HARDY DIAGNOSTICS › N/A

N/A

HARDY DIAGNOSTICS · Model Q23 · UDI-DI 00819398022798

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

Description

Nutrient Gelatin Deep, 6ml, 15x103mm pour tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the detection of the ability of bacteria to liquefy gelatin.

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.